Type 2 Diabetes, Obesity
Conditions
Keywords
Diabetes, Obesity, Weight management, Diabetes education, Diabetes remission
Brief summary
The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team. If shown to be efficacious, this research could be highly impactful, causing us to rethink our approach to care for those with T2DM and shift the paradigm for millions of individuals in the United States. Furthermore, this approach will demonstrate the feasibility of helping people engage in metabolic treatment strategies in a way that is scalable leveraging digital and mobile solutions that extend the patient-provider relationship, shift care from episodic approaches to more of an on-going model that extends into the life of the patient, while also integrated within the healthcare system workflows.
Detailed description
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is \< 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months.Using a randomized controlled study design, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
Interventions
BEHAVIORALMedical weight loss
Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
BEHAVIORALDiabetes education
Participants will receive standard of care diabetes education
BEHAVIORALContinuous glucose monitoring
Participants will use CGM devices to track blood glucose levels in near real time
Sponsors
Wake Forest University Health Sciences
UnitedHealth Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Individuals with T2DM diagnosed within the past 6 years * Body Mass Index (BMI) of 30-39.9 kg/m2. * Participants must have an HbA1c between 6.5-11.9%. * Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling.
Exclusion criteria
* Poorly controlled depression * Recent hospitalization for psychosis or bipolar disorder * Poorly controlled blood pressure (\>159/99) * Prior surgical procedure for weight control or liposuction * Unable to make changes to their diet * Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests) * Use of weight loss medications in previous 3 months * Recent self-reported weight change (+/- 15lbs) * Current use of oral corticosteroids more than 5days/month * Cardiovascular disease event within the past 6 months * Severe pulmonary disease requiring supplemental oxygen * Renal failure (end stage renal disease) * History of non-skin cancer in the past 5 years * Major liver dysfunction within the last 2 years * Recently quit smoking less than 6 months prior * Inability to attend visits and adhere to study protocols * Pregnancy or currently lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | baseline through 12 months | Change in weight from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | baseline through 12 months | Change in hemoglobin A1c |
| Number of Subjects in Diabetes Remission | 12 months | Number of participants achieving A1c \<6.5% and no anti-diabetes medications |
| Continuous Glucose Monitoring (CGM) Time in Range | baseline and month 12 | Average time spent at an average glucose of 100 mg/dL or lower collected by FreeStyle Libre. |
| Continuous Glucose Monitoring Time in Range--Post-meal Glucose | baseline through 12 months | Average time spent at a post-meal glucose level of 110 mg/dL or lower collected by FreeStyle Libre. |
| Continuous Glucose Monitor Time in Range--Fasting Glucose | baseline through 12 months | Average time spent in normal fasting glucose between 72-85 mg/dL collected by FreeStyle Libre. |
| Continuous Glucose Monitor - Episodes of Hypoglycemia | baseline and month 12 | Number of episodes hypoglycemia (\<70 mg/dL) episodes collected by FreeStyle Libre. |
| Continuous Glucose Monitor - Glucose Variability | baseline and month 12 | Coefficient of variance collected by FreeStyle Libre. |
| Continuous Glucose Monitoring - Average Glucose | baseline and 12 months | Average glucose (mg/dL) collected by FreeStyle Libre. |
| Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake | baseline, 3 months, 6 months, and 12 months | kilocalories averaged across 3 days |
| ASA24 Macronutrient Composition of Diet | baseline, 3 months, 6 months, and 12 months | %Carbohydrate/Fat/Protein; averaged across 3 days |
| ASA24 Number of Eating Episodes Per Day | baseline, 3 months, 6 months, and 12 months | averaged across 3 days |
| ASA24 Healthy Eating Index (HEI)-2015 Score | baseline, 3 months, 6 months, and 12 months | A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality |
| Daily Step Counts | baseline, 3 months, 6 months, and 12 months | Collected by pedometer over 7 days during each period. At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope. |
| Change in Quality of Life | from baseline to month 12 | The EuroQol's EQ-5D-5L will be used to measure quality of life. This instrument takes responses to five questions on mobility, self-care, ability to perform usual activities, pain, and anxiety/depression to produce a validated quality score. Total score range is 5-25 with a lower score indicating a better quality of life. |
| Change in Perceived Health Rating | from baseline to month 12 | The EuroQol's EQ-5D-5L visual analog scale will be used to measure participants perceived health. On a scale of 0-100 participants will rate their health. 0 means the worst health you can imagine. 100 means the best health you can imagine. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJamy Ard, MD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.17 years STANDARD_DEVIATION 11.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 22 | 0 / 22 | 0 / 20 |
| other Total, other adverse events | 8 / 22 | 2 / 22 | 5 / 20 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 | 0 / 20 |
Outcome results
None listed