Diabetes Mellitus, Diabetes Type 2, Obesity
Conditions
Keywords
Obesity, Diabetes, Neurophysiology, Cryovagotomy, Glycemic control
Brief summary
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.
Detailed description
Obesity is a growing epidemic, currently affecting over 1/3 of the adult US population and is a well-established risk factor for the development of diabetes and cardiovascular disease. Given that the majority of patients with type 2 diabetes (T2D) are obese, weight loss is the cornerstone of treatment, and has been shown to decrease risk of long term complications, lead to improvements in A1c and lipid levels, as well as decreased need for medications and improvements in quality of life. Unfortunately, lifestyle intervention is often ineffective at achieving long-term sustainable, clinically significant weight loss. Bariatric surgery is a successful intervention, leading to 20-30% weight loss with remission of diabetes in 30-65% of patients 1-5 years post surgery. However, this invasive procedure is associated with high rates of short- and long-term complications, including need for reoperations, vitamin/mineral deficiencies, anemia, and osteoporosis. It is clear that the current management options for obese patients, including lifestyle changes, medications and surgery, are suboptimal and innovative strategies are necessary to optimize diabetes control and weight management. Energy balance and glycemic control are mediated largely by the gut-brain axis, specifically the vagus nerve. The vagus nerve can stimulate or inhibit food intake depending on nutritional status. Vagal nerve signaling is disrupted in the setting of obesity and thought to contribute to overeating behaviors. Vagus nerve blockade has the potential to be a highly efficacious, minimally invasive intervention to address current obesity treatment limitations. Clinical studies evaluating the efficacy of an implantable electric vagus nerve blockade device found that subjects lost on average 8.8% of total body weight at 1 year; patients with T2D experienced improved glycemic control, with an average A1c improvement of 1.0% at 12 months. Unfortunately, nearly 40% of subjects experienced side effects related to the device. A recent pilot study from the researchers of this study reported weight loss efficacy of a minimally invasive computerized tomography (CT) guided cryoablation of the vagus nerve in obese, non-diabetic subjects. Patients lost 5.6% of total body weight and 22.7% excess body weight at 6 months with no significant side effects. The purpose of this current study is to evaluate the feasibility and efficacy of this procedure through a randomized control trial in obese patients with T2D. The researchers hypothesize that those patients undergoing the cryoablation procedure will experience improvement in glycemic control and enhanced weight loss at 6 months follow-up compared to the control group. Participants will be randomized to receive either CT guided cryoablation of the vagus nerve plus lifestyle intervention or lifestyle intervention alone. The lifestyle intervention lasts for 26 weeks and participants will be followed for 12 months in total.
Interventions
DEVICECryoablation of the Vagus Nerve
The Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology. The procedure will be done under CT guidance and involves a 4-5 mm scalpel incision followed by percutaneous probe placement about the posterior gastroesophageal junction (the location of the posterior vagal trunk). The probe will create a zone of decreased temperature (-20 to -40 degrees Celsius) involving the posterior vagal nerve fibers/plexus. The cryoablation process will include a 3-minute freeze, followed by a 1-minute thaw, and a second 3-minute freeze and 1 minute thaw.
BEHAVIORALLifestyle Intervention
The lifestyle intervention structure will include three face-to-face counseling sessions at baseline, 3 and 6 months. Dietary counseling to follow a low carbohydrate diet will be provided by a registered dietitian. Focus will be on increasing fruits and vegetables and decreasing refined sugars and processed foods. It will also include motivational interviewing, goal setting and nutrition education. In addition, subjects will be encouraged by exercise physiologist to slowly increase physical activity to at least 150 minutes weekly. There will be weekly phone calls or texts (participants' choice) providing a total of 26 points of contact recommended by the United States Preventive Services Task Force.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between the ages of 22-65 2. Diagnosis of type 2 diabetes mellitus (T2DM) for \<10 years 3. HbA1c between ≥7.5% and ≤10.5% 4. Treatment with non-insulin antidiabetic medications with stable doses for at least 3 months, with failed prior attempts at dietary interventions to optimize diabetes control 5. BMI 30-40 kg/m\^2 6. Willing to comply with study requirements 7. Documented negative pregnancy test in women of child bearing potential and use of an effective birth control method 8. Average score of ≥3 on questions 4, 8, 9, 13, and 14 from the Three Factor Eating Questionnaire
Exclusion criteria
1. Diagnosis of type 1 diabetes or history of diabetic ketoacidosis 2. Use of insulin therapy 3. Significant kidney disease (eGFR \< 60 ml/min/1.73m\^2) 4. Current drug or alcohol addiction 5. Thyroid disease unless underlying diagnosis is primary hypothyroidism on stable medications for \>3 months with thyroid stimulating hormone (TSH) in reference range at time of screening visit 6. Systemic steroid use within 30 days prior to randomization 7. Use of prescription or over the counter weight loss medications within 6 months prior to randomization 8. Weight gain/loss \>5% over the past 6 months 9. Previous GI surgery or abnormal GI anatomy which may limit technical feasibility of the procedure 10. Recent diagnosis of cardiovascular disease requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the past 6 months 11. Abnormal pathologies or conditions of the GI tract, including peptic ulcers, hiatal hernia, active gallbladder disease, pancreatitis, cirrhosis, inflammatory bowel disease, upper GI bleed within 6 months of randomization 12. Any condition or major illness that places the subject at undue risk by participating in the study 13. Psychiatric condition rendering the subject unable to understand the possible consequences of the study 14. Inability to provide informed consent 15. Female subjects who have been pregnant within 6 months or breast-feeding at time of enrollment into the study, or women who plan to become pregnant within the next 12 months 16. Diagnosis of anemia, red blood cell (RBC) transfusion in the preceding 3 months or expectation to receive transfusion within the next 12 months, or hemoglobinopathies that would affect HbA1c reliability 17. Active or recent infection 18. Immunosuppression 19. History of coagulopathy or high risk for development of deep vein thrombosis (including congestive heart failure, those who are non-ambulatory, active leukemia/lymphoma, prior thrombotic events, family history of thrombosis) 20. History of blood pressure instability (systolic BP ≤100 or ≥160 mmHg) 21. History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Baseline, Month 3, Month 6, Month 12 | The hemoglobin A1c test result reflects average blood sugar level for the past two to three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). The higher A1c level, the poorer blood sugar control and the higher risk of diabetes complications. |
| Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, Month 3, Month 6, Month 12 | Insulin resistance score HOMA-IR is computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). |
| Number of Deaths Among Recipients of the Cryoablation | Up to Month 12 | Mortality among recipients of the cryoablation was documented. |
| Number of Adverse Events Related to the Cryoablation | Up to Month 12 | The count of procedure related complications, such as bleeding, infection, pneumothorax, hemothorax, pulmonary injury, complications of sedation, pain requiring hospital admission or treatment, dysphagia, gastroparesis, nausea and vomiting, and gastrointestinal ulceration was documented for the duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | Baseline, Month 3, Month 6 | A normal diastolic blood pressure level is less than 80 mmHg. |
| Daily Caloric Intake | Baseline, Month 3, Month 6 | Daily caloric intake is measured by 3-day food recall. Mean daily caloric intake is assessed as kilocalories (kcal) consumed per day. |
| Body Mass Index (BMI) | Baseline, Month 3, Month 6 | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. |
| Waist Circumference | Baseline, Month 3, Month 6 | Waist circumference is a measurement taken around the abdomen at the level of the umbilicus (belly button). Waist circumference is measured in centimeters. |
| Waist-to-hip Ratio | Baseline, Month 3, Month 6 | A waist-to-hip ratio of greater than 1.0 indicates a higher risk of developing heart disease. For women, a healthy waist-to-hip ratio is less than 0.85 while under 0.9 is a healthy ratio for men. |
| Change in Anti-hyperglycemic Medication Regimen | Month 3, Month 6 | Anti-hyperglycemic medications will be adjusted at visits under the direction of the endocrinologist, or as needed for clinically significant hypo- or hyperglycemic events. Changes in baseline medication regimen will be examined to determine if medication needs decrease or increase during the study. |
| Appetite Visual Analog Scale Score for Hunger | Baseline, Week 1, Month 1, Month 3, Month 6 | The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for hunger asks participants how hungry they feel, where 0 = not at all and 100 = never been more hungry. |
| Total Cholesterol | Baseline, Month 6 | A healthy level of total cholesterol is 125 - 200 mg/dL. |
| Appetite Visual Analog Scale Score for Fullness | Baseline, Week 1, Month 1, Month 3, Month 6 | The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for fullness asks participants how full they feel, where 0 = not full at all and 100 = totally full. |
| Appetite Visual Analog Scale Score for Eating Quantity | Baseline, Week 1, Month 1, Month 3, Month 6 | The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for eating quantity asks participants how much they think they can eat, where 0 = nothing at all and 100 = a lot. |
| Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline, Week 1, Month 1, Month 3, Month 6 | The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. Four items of the questionnaire ask participants if they would like to eat something sweet, salty, savory, and fatty. Each item is scored as 0 = yes, very much and 100 = no, not at all. |
| International Physical Activity Questionnaire (IPAQ) Score | Baseline, Month 3, Month 6 | The IPAQ assesses physical activity during the past 7 days with 27 items. Based on the type, duration, and frequency of activity, respondents are categorized as having low activity, moderate activity, or high activity. |
| Fasting Glucose Level | Baseline, Month 3, Month 6 | A normal fasting blood sugar level is 99 mg/dL or lower, glucose levels of 100 - 125 mg/dL indicates prediabetes, and levels of 126 mg/dL and higher indicates diabetes. |
| Fasting Insulin Level | Baseline, Month 3, Month 6 | A normal fasting insulin level for the Emory Healthcare Laboratory is 1.9 to 23.0 milli-international units per liter (mIU/L). High levels of fasting insulin are associated with obesity and early stage type 2 diabetes (T2D). Type 1 diabetes and advanced T2D are associated with low levels of insulin. |
| Appetite Visual Analog Scale Score for Satisfaction | Baseline, Week 1, Month 1, Month 3, Month 6 | The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for satisfaction asks participants how satisfied they feel, where 0 = completely empty and 100 = cannot eat another bite. |
| Low-Density Lipoprotein (LDL) | Baseline, Month 6 | A healthy level of LDL is less than 100 mg/dL. |
| Triglycerides | Baseline, Month 6 | A healthy level of triglycerides is less than 150 mg/dL. |
| Systolic Blood Pressure | Baseline, Month 3, Month 6 | A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Emory University Hospital and Clinics, and Grady Health System in Atlanta, Georgia, USA. Participant enrollment began October 23, 2020 and all follow-up assessments were completed by February 8, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention Participants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. | 2 |
| Lifestyle Intervention Only Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Lifestyle Intervention Only |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 54.2 years STANDARD_DEVIATION 9.3 | 53.5 years STANDARD_DEVIATION 10.5 | 54.7 years STANDARD_DEVIATION 8.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 5 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 2 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Hemoglobin A1c
The hemoglobin A1c test result reflects average blood sugar level for the past two to three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). The higher A1c level, the poorer blood sugar control and the higher risk of diabetes complications.
Time frame: Baseline, Month 3, Month 6, Month 12
Population: This analysis includes participants who attended the indicated study visit. One participant from the cryoablation plus lifestyle intervention group withdrew after the Month 6 visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Hemoglobin A1c | Baseline | 8.35 percent of glycated hemoglobin | Standard Deviation 0.25 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Hemoglobin A1c | Month 3 | 8.75 percent of glycated hemoglobin | Standard Deviation 0.05 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Hemoglobin A1c | Month 6 | 8.40 percent of glycated hemoglobin | Standard Deviation 0.2 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Hemoglobin A1c | Month 12 | 9.30 percent of glycated hemoglobin | Standard Deviation 0 |
| Lifestyle Intervention Only | Hemoglobin A1c | Baseline | 8.86 percent of glycated hemoglobin | Standard Deviation 0.4 |
Primary
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance score HOMA-IR is computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
Time frame: Baseline, Month 3, Month 6, Month 12
Population: This analysis includes participants who attended the indicated study visit. One participant from the cryoablation plus lifestyle intervention group withdrew after the Month 6 visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline | 7.85 (mmol/l X mU/l) / 22.5 | Standard Deviation 1.75 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Month 3 | 7.00 (mmol/l X mU/l) / 22.5 | Standard Deviation 1 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Month 6 | 10.70 (mmol/l X mU/l) / 22.5 | Standard Deviation 1.6 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Month 12 | 7.00 (mmol/l X mU/l) / 22.5 | Standard Deviation 0 |
| Lifestyle Intervention Only | Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline | 4.70 (mmol/l X mU/l) / 22.5 | Standard Deviation 2.94 |
Primary
Number of Adverse Events Related to the Cryoablation
The count of procedure related complications, such as bleeding, infection, pneumothorax, hemothorax, pulmonary injury, complications of sedation, pain requiring hospital admission or treatment, dysphagia, gastroparesis, nausea and vomiting, and gastrointestinal ulceration was documented for the duration of the study.
Time frame: Up to Month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Number of Adverse Events Related to the Cryoablation | 0 related complications |
Primary
Number of Deaths Among Recipients of the Cryoablation
Mortality among recipients of the cryoablation was documented.
Time frame: Up to Month 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Number of Deaths Among Recipients of the Cryoablation | 0 Participants |
Secondary
Appetite Visual Analog Scale Score for Desire for Certain Foods
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. Four items of the questionnaire ask participants if they would like to eat something sweet, salty, savory, and fatty. Each item is scored as 0 = yes, very much and 100 = no, not at all.
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 6 - Fatty | 70 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 3 - Salty | 46.5 units on a scale | Standard Deviation 1.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 6 - Salty | 53 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Savory | 11 units on a scale | Standard Deviation 11 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Savory | 44 units on a scale | Standard Deviation 22 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Savory | 71.5 units on a scale | Standard Deviation 2.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 3 - Savory | 43.5 units on a scale | Standard Deviation 16.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 6 - Savory | 25 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Fatty | 34.5 units on a scale | Standard Deviation 34.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Fatty | 57 units on a scale | Standard Deviation 12 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Fatty | 74.5 units on a scale | Standard Deviation 1.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 3 - Fatty | 51.5 units on a scale | Standard Deviation 6.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Sweet | 23.5 units on a scale | Standard Deviation 23.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Sweet | 37 units on a scale | Standard Deviation 32 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Sweet | 75 units on a scale | Standard Deviation 13 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 3 - Sweet | 42.5 units on a scale | Standard Deviation 7.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 6 - Sweet | 47 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Salty | 23 units on a scale | Standard Deviation 23 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Salty | 57.5 units on a scale | Standard Deviation 11.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Salty | 32 units on a scale | Standard Deviation 8 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Sweet | 49.33 units on a scale | Standard Deviation 40.83 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Salty | 53 units on a scale | Standard Deviation 13 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Sweet | 41.5 units on a scale | Standard Deviation 10.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Fatty | 38 units on a scale | Standard Deviation 20 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Sweet | 71 units on a scale | Standard Deviation 9 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Savory | 62.5 units on a scale | Standard Deviation 11.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Fatty | 60.66 units on a scale | Standard Deviation 32.26 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Savory | 46 units on a scale | Standard Deviation 36.8 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Baseline - Salty | 53.33 units on a scale | Standard Deviation 31.75 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Month 1 - Fatty | 60.5 units on a scale | Standard Deviation 12.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Salty | 57.5 units on a scale | Standard Deviation 12.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Desire for Certain Foods | Week 1 - Savory | 61.5 units on a scale | Standard Deviation 1.5 |
Secondary
Appetite Visual Analog Scale Score for Eating Quantity
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for eating quantity asks participants how much they think they can eat, where 0 = nothing at all and 100 = a lot.
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Eating Quantity | Month 6 | 75 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Eating Quantity | Month 1 | 35 units on a scale | Standard Deviation 10 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Eating Quantity | Month 3 | 31.5 units on a scale | Standard Deviation 7.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Eating Quantity | Baseline | 74.5 units on a scale | Standard Deviation 25.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Eating Quantity | Week 1 | 38 units on a scale | Standard Deviation 11 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Eating Quantity | Baseline | 42.33 units on a scale | Standard Deviation 13.88 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Eating Quantity | Month 1 | 45 units on a scale | Standard Deviation 20 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Eating Quantity | Week 1 | 52.5 units on a scale | Standard Deviation 13.5 |
Secondary
Appetite Visual Analog Scale Score for Fullness
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for fullness asks participants how full they feel, where 0 = not full at all and 100 = totally full.
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Fullness | Month 6 | 14 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Fullness | Month 1 | 77.5 units on a scale | Standard Deviation 20.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Fullness | Month 3 | 53.5 units on a scale | Standard Deviation 46.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Fullness | Baseline | 2 units on a scale | Standard Deviation 2 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Fullness | Week 1 | 37.5 units on a scale | Standard Deviation 33.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Fullness | Baseline | 19.66 units on a scale | Standard Deviation 21.45 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Fullness | Month 1 | 36 units on a scale | Standard Deviation 21 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Fullness | Week 1 | 28.5 units on a scale | Standard Deviation 21.5 |
Secondary
Appetite Visual Analog Scale Score for Hunger
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for hunger asks participants how hungry they feel, where 0 = not at all and 100 = never been more hungry.
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Hunger | Month 6 | 75 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Hunger | Baseline | 98 units on a scale | Standard Deviation 2 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Hunger | Week 1 | 60.5 units on a scale | Standard Deviation 35.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Hunger | Month 1 | 26.5 units on a scale | Standard Deviation 16.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Hunger | Month 3 | 34 units on a scale | Standard Deviation 27 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Hunger | Month 1 | 46 units on a scale | Standard Deviation 3 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Hunger | Week 1 | 60.5 units on a scale | Standard Deviation 0.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Hunger | Baseline | 50 units on a scale | Standard Deviation 37.96 |
Secondary
Appetite Visual Analog Scale Score for Satisfaction
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for satisfaction asks participants how satisfied they feel, where 0 = completely empty and 100 = cannot eat another bite.
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Satisfaction | Month 6 | 35 units on a scale | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Satisfaction | Month 1 | 72 units on a scale | Standard Deviation 19 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Satisfaction | Month 3 | 51 units on a scale | Standard Deviation 20 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Satisfaction | Baseline | 2.5 units on a scale | Standard Deviation 2.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Appetite Visual Analog Scale Score for Satisfaction | Week 1 | 37 units on a scale | Standard Deviation 32 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Satisfaction | Baseline | 19 units on a scale | Standard Deviation 21.95 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Satisfaction | Month 1 | 41.5 units on a scale | Standard Deviation 11.5 |
| Lifestyle Intervention Only | Appetite Visual Analog Scale Score for Satisfaction | Week 1 | 41.5 units on a scale | Standard Deviation 10.5 |
Secondary
Body Mass Index (BMI)
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Time frame: Baseline, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Body Mass Index (BMI) | Baseline | 37.25 kg/m^2 | Standard Deviation 1.55 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Body Mass Index (BMI) | Month 3 | 37.25 kg/m^2 | Standard Deviation 0.25 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Body Mass Index (BMI) | Month 6 | 39.5 kg/m^2 | Standard Deviation 0 |
| Lifestyle Intervention Only | Body Mass Index (BMI) | Baseline | 33.26 kg/m^2 | Standard Deviation 3.71 |
Secondary
Change in Anti-hyperglycemic Medication Regimen
Anti-hyperglycemic medications will be adjusted at visits under the direction of the endocrinologist, or as needed for clinically significant hypo- or hyperglycemic events. Changes in baseline medication regimen will be examined to determine if medication needs decrease or increase during the study.
Time frame: Month 3, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Change in Anti-hyperglycemic Medication Regimen | No change in dose from Baseline to Month 3 | 1 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Change in Anti-hyperglycemic Medication Regimen | Dose Increase from Baseline to Month 3 | 1 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Change in Anti-hyperglycemic Medication Regimen | No Change in Dose from Month 3 to Month 6 | 2 Participants |
Secondary
Daily Caloric Intake
Daily caloric intake is measured by 3-day food recall. Mean daily caloric intake is assessed as kilocalories (kcal) consumed per day.
Time frame: Baseline, Month 3, Month 6
Population: The 3-day food recall diary was not completed by any study participants.
Secondary
Diastolic Blood Pressure
A normal diastolic blood pressure level is less than 80 mmHg.
Time frame: Baseline, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Diastolic Blood Pressure | Baseline | 80.00 mmHg | Standard Deviation 2 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Diastolic Blood Pressure | Month 3 | 74.00 mmHg | Standard Deviation 0 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Diastolic Blood Pressure | Month 6 | 80.00 mmHg | Standard Deviation 0 |
| Lifestyle Intervention Only | Diastolic Blood Pressure | Baseline | 80.66 mmHg | Standard Deviation 8.21 |
Secondary
Fasting Glucose Level
A normal fasting blood sugar level is 99 mg/dL or lower, glucose levels of 100 - 125 mg/dL indicates prediabetes, and levels of 126 mg/dL and higher indicates diabetes.
Time frame: Baseline, Month 3, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Glucose Level | Baseline | 197 mg/dL | Standard Deviation 25 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Glucose Level | Month 3 | 186.5 mg/dL | Standard Deviation 28.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Glucose Level | Month 6 | 151.5 mg/dL | Standard Deviation 4.5 |
| Lifestyle Intervention Only | Fasting Glucose Level | Baseline | 166.33 mg/dL | Standard Deviation 4.64 |
Secondary
Fasting Insulin Level
A normal fasting insulin level for the Emory Healthcare Laboratory is 1.9 to 23.0 milli-international units per liter (mIU/L). High levels of fasting insulin are associated with obesity and early stage type 2 diabetes (T2D). Type 1 diabetes and advanced T2D are associated with low levels of insulin.
Time frame: Baseline, Month 3, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Insulin Level | Baseline | 15.9 mIU/L | Standard Deviation 1.6 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Insulin Level | Month 3 | 16.5 mIU/L | Standard Deviation 4.1 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Fasting Insulin Level | Month 6 | 18.65 mIU/L | Standard Deviation 6.35 |
| Lifestyle Intervention Only | Fasting Insulin Level | Baseline | 11.6 mIU/L | Standard Deviation 7.65 |
Secondary
International Physical Activity Questionnaire (IPAQ) Score
The IPAQ assesses physical activity during the past 7 days with 27 items. Based on the type, duration, and frequency of activity, respondents are categorized as having low activity, moderate activity, or high activity.
Time frame: Baseline, Month 3, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 6 - High activity | 0 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 6 - Low activity | 2 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 6 - Moderate activity | 0 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Baseline - Low activity | 0 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Baseline - Moderate activity | 0 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Baseline - High activity | 2 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 3 - Low activity | 1 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 3 - Moderate activity | 1 Participants |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | International Physical Activity Questionnaire (IPAQ) Score | Month 3 - High activity | 0 Participants |
| Lifestyle Intervention Only | International Physical Activity Questionnaire (IPAQ) Score | Baseline - Low activity | 1 Participants |
| Lifestyle Intervention Only | International Physical Activity Questionnaire (IPAQ) Score | Baseline - High activity | 0 Participants |
| Lifestyle Intervention Only | International Physical Activity Questionnaire (IPAQ) Score | Baseline - Moderate activity | 2 Participants |
Secondary
Low-Density Lipoprotein (LDL)
A healthy level of LDL is less than 100 mg/dL.
Time frame: Baseline, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Low-Density Lipoprotein (LDL) | Baseline | 120.5 mg/dL | Standard Deviation 30.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Low-Density Lipoprotein (LDL) | Month 6 | 102.0 mg/dL | Standard Deviation 36 |
| Lifestyle Intervention Only | Low-Density Lipoprotein (LDL) | Baseline | 121.33 mg/dL | Standard Deviation 30.61 |
Secondary
Systolic Blood Pressure
A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg).
Time frame: Baseline, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Systolic Blood Pressure | Baseline | 127.00 mmHg | Standard Deviation 14 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Systolic Blood Pressure | Month 3 | 112.50 mmHg | Standard Deviation 5.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Systolic Blood Pressure | Month 6 | 113.0 mmHg | Standard Deviation 0 |
| Lifestyle Intervention Only | Systolic Blood Pressure | Baseline | 139.66 mmHg | Standard Deviation 8.17 |
Secondary
Total Cholesterol
A healthy level of total cholesterol is 125 - 200 mg/dL.
Time frame: Baseline, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Total Cholesterol | Baseline | 198.00 mg/dL | Standard Deviation 39 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Total Cholesterol | Month 6 | 179.00 mg/dL | Standard Deviation 42 |
| Lifestyle Intervention Only | Total Cholesterol | Baseline | 194.33 mg/dL | Standard Deviation 39.19 |
Secondary
Triglycerides
A healthy level of triglycerides is less than 150 mg/dL.
Time frame: Baseline, Month 6
Population: This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Triglycerides | Baseline | 110 mg/dL | Standard Deviation 16 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Triglycerides | Month 6 | 85 mg/dL | Standard Deviation 9 |
| Lifestyle Intervention Only | Triglycerides | Baseline | 151 mg/dL | Standard Deviation 82 |
Secondary
Waist Circumference
Waist circumference is a measurement taken around the abdomen at the level of the umbilicus (belly button). Waist circumference is measured in centimeters.
Time frame: Baseline, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist Circumference | Baseline | 121.3 cm | Standard Deviation 9.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist Circumference | Month 3 | 117.5 cm | Standard Deviation 2.5 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist Circumference | Month 6 | 127 cm | Standard Deviation 0 |
| Lifestyle Intervention Only | Waist Circumference | Baseline | 147.66 cm | Standard Deviation 58.39 |
Secondary
Waist-to-hip Ratio
A waist-to-hip ratio of greater than 1.0 indicates a higher risk of developing heart disease. For women, a healthy waist-to-hip ratio is less than 0.85 while under 0.9 is a healthy ratio for men.
Time frame: Baseline, Month 3, Month 6
Population: One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist-to-hip Ratio | Baseline | 0.97 waist cm/hip cm | Standard Deviation 0.02 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist-to-hip Ratio | Month 3 | 0.95 waist cm/hip cm | Standard Deviation 0.05 |
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Waist-to-hip Ratio | Month 6 | 1.0 waist cm/hip cm | Standard Deviation 0 |
| Lifestyle Intervention Only | Waist-to-hip Ratio | Baseline | 1.06 waist cm/hip cm | Standard Deviation 0.04 |