Bariatric Surgery Candidate
Conditions
Keywords
Bariatric surgery, Obesity, Insulin sensitivity, Exercise intervention
Brief summary
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose). Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery. Researchers will compare the effects of walking before bariatric surgery on: * Insulin sensitivity (diabetes risk factor) * Health of blood vessels * Rate of complications after surgery * Weight * Body Fat * Fitness level
Detailed description
The purpose of the present study is to evaluate the impact of 8 weeks of supervised aerobic exercise prior to bariatric surgery on insulin sensitivity using the hyperinsulinemic-euglycemic clamp. Participants will be recruited from the area surrounding the UVA hospital, while the primary outcome will be insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp procedure and secondary outcomes include the effects of the exercise intervention on surgical outcomes and cardiometabolic and arterial health in bariatric patients. Objectives: Primary Objective: To investigate the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery. Secondary Objectives: To examine the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes, such as length of stay post-surgery, and other clinically relevant outcomes, such as cardiometabolic and arterial health, in adults following bariatric surgery. Hypotheses: Primary Hypothesis: An 8-week exercise intervention before bariatric surgery will improve insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp following bariatric surgery. Secondary Hypothesis: An 8-week exercise intervention will improve clinically relevant post-surgical outcomes, such as surgical outcomes, quality of life, arterial health, and other cardiometabolic factors following bariatric surgery.
Interventions
OTHERExercise Group
Previously sedentary adults awaiting bariatric surgery will be randomized to either an Exercise group (EX-group) or Standard care only group (SC-group) for 8 weeks. Outcome visits will occur before the exercise intervention, after the exercise intervention, and after surgery
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team.
Intervention model description
In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* BMI: 35 - 45 kg/m2. For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study. * Considered sedentary based on self-reported inactivity of \< 2-3 x/week of MVPA within previous 3 months before enrollment. * Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes. * Surgery approved within 6-9 months of initial visit. * Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate. * Willingness to accept group randomization assignment.
Exclusion criteria
* Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease. * Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis. * HIV or tuberculosis. * Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc). * Resting SBP \> 150 mmHg, DBP \> 100 mmHg. * Current pregnancy or plans to become pregnant during intervention. * Plans to be away from the Charlottesville, VA area for \> 1 week during intervention or plans of relocating during the intervention. * Any medical or health condition (e.g., musculoskeletal, orthopedic, or neurological conditions) that is contraindicated for safe exercise testing and training. * Previous weight-loss surgeries or revisions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | Change from baseline to after surgery (12 weeks) | Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical outcomes - IV treatment as an outpatient | Change from baseline to after surgery (12 weeks) | Variables recorded after surgery such as IV treatment as an outpatient |
| Surgical outcomes - emergency department visits | Change from baseline to after surgery (12 weeks) | Variables recorded after surgery such as emergency department visits |
| Surgical outcomes - time of surgery | Intraoperative | Variables recorded after surgery such as time of surgery (min). |
| Surgical outcomes - length of stay after surgery completion | Change from baseline to after surgery (12 weeks) | Variables recorded after surgery such as length of stay after surgery |
| Flow-mediated dilation (FMD) | Change from baseline to after surgery (12 weeks) | Endothelial function measured via flow mediated dilation (FMD) (%) - indication of shear-stress-mediated dilation following occlusion |
| Pulse-wave analysis (PWA) | Change from baseline to after surgery (12 weeks) | Pulse-wave analysis (PWA) as measured with a SphygmoCor Xcel to measure brachial systolic and diastolic pressures and to capture a brachial waveform. |
| Pulse-wave velocity (PWV) | Change from baseline to after surgery (12 weeks) | Pulse-wave velocity (PWV) as measured with a SphygmoCor Xcel to measure the blood pressure waveforms at the carotid and femoral artery sites. |
| Body fat | Change from baseline to after surgery (12 weeks) | Dual-energy x-ray absorptiometry (DEXA) will be used to access body fat (g) |
| Lean body mass | Change from baseline to after surgery (12 weeks) | Dual-energy x-ray absorptiometry (DEXA) will be used to access lean body mass |
| Surgical outcomes - readmission within 30 days of surgery | within 30 days | Variables recorded after surgery such as readmission within 30 days of surgery |
| Visceral adiposity | Change from baseline to after surgery (12 weeks) | Dual-energy x-ray absorptiometry (DEXA) will be used to access visceral adiposity measures (g) |
| Weight | Change from baseline to after surgery (12 weeks) | Body weight measured on a level beam scale; minimum value 0 kg-500kg; higher scores tend to suggest worsened outcomes |
| Blood Lipids | Change from baseline to after surgery (12 weeks) | Cholesterol values, including HDL-C, LDL-C, and VLDL-C (mg/dL) from intravenous line |
| Plasma glucose | Change from baseline to after surgery (12 weeks) | Plasma glucose (mg/dL) from intravenous line |
| Plasma insulin | Change from baseline to after surgery (12 weeks) | Plasma insulin (uIU/dL) from intravenous line |
| Hemoglobin A1c | up to 12 weeks | Hemoglobin A1C (%) - an average of blood glucose levels in the previous 3 months |
| Cardiorespiratory fitness | Change from baseline to after surgery (12 weeks) | Vo2 max measured via a maximal exercise test on a treadmill |
| Quality of life (SF-36) | Change from baseline to after surgery (12 weeks) | Quality of life will be assessed via the SF-36 and the variables included in the questionnaire are physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) |
| Bone mineral density | Change from baseline to after surgery (12 weeks) | Dual-energy x-ray absorptiometry (DEXA) will be used to access bone mineral density (g) |
Countries
United States
Outcome results
None listed