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Project during development was discontinued before the enrollment of participants
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group (EX-group) | Experimental | The EX-group will complete 8 weeks of supervised aerobic exercise training. The EX-group will also continue normal care with bariatric doctors and nurses along with the exercise intervention. |
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| Standard Care Only Group (SC-group) | No Intervention | The SC-group will only complete the orientation visit and testing visits. The participants that are randomized to this group will continue normal care with bariatric doctors and nurses. They will participate in study assessment visits only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Group | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp | Change from baseline to after surgery (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical outcomes - readmission within 30 days of surgery | Variables recorded after surgery such as readmission within 30 days of surgery | within 30 days |
| Surgical outcomes - IV treatment as an outpatient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22902 | United States |
IPD that underlie results in a publication.
Within 1 year of study completion
Access to UVA Health portals, including UVA Health REDCap
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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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.
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Variables recorded after surgery such as IV treatment as an outpatient
| Change from baseline to after surgery (12 weeks) |
| Surgical outcomes - emergency department visits | Variables recorded after surgery such as emergency department visits | Change from baseline to after surgery (12 weeks) |
| Surgical outcomes - time of surgery | Variables recorded after surgery such as time of surgery (min). | Intraoperative |
| Surgical outcomes - length of stay after surgery completion | Variables recorded after surgery such as length of stay after surgery | Change from baseline to after surgery (12 weeks) |
| Flow-mediated dilation (FMD) | Endothelial function measured via flow mediated dilation (FMD) (%) - indication of shear-stress-mediated dilation following occlusion | Change from baseline to after surgery (12 weeks) |
| Pulse-wave analysis (PWA) | Pulse-wave analysis (PWA) as measured with a SphygmoCor Xcel to measure brachial systolic and diastolic pressures and to capture a brachial waveform. | Change from baseline to after surgery (12 weeks) |
| Pulse-wave velocity (PWV) | Pulse-wave velocity (PWV) as measured with a SphygmoCor Xcel to measure the blood pressure waveforms at the carotid and femoral artery sites. | Change from baseline to after surgery (12 weeks) |
| Body fat | Dual-energy x-ray absorptiometry (DEXA) will be used to access body fat (g) | Change from baseline to after surgery (12 weeks) |
| Lean body mass | Dual-energy x-ray absorptiometry (DEXA) will be used to access lean body mass | Change from baseline to after surgery (12 weeks) |
| Bone mineral density | Dual-energy x-ray absorptiometry (DEXA) will be used to access bone mineral density (g) | Change from baseline to after surgery (12 weeks) |
| Visceral adiposity | Dual-energy x-ray absorptiometry (DEXA) will be used to access visceral adiposity measures (g) | Change from baseline to after surgery (12 weeks) |
| Weight | Body weight measured on a level beam scale; minimum value 0 kg-500kg; higher scores tend to suggest worsened outcomes | Change from baseline to after surgery (12 weeks) |
| Blood Lipids | Cholesterol values, including HDL-C, LDL-C, and VLDL-C (mg/dL) from intravenous line | Change from baseline to after surgery (12 weeks) |
| Plasma glucose | Plasma glucose (mg/dL) from intravenous line | Change from baseline to after surgery (12 weeks) |
| Plasma insulin | Plasma insulin (uIU/dL) from intravenous line | Change from baseline to after surgery (12 weeks) |
| Hemoglobin A1c | Hemoglobin A1C (%) - an average of blood glucose levels in the previous 3 months | up to 12 weeks |
| Cardiorespiratory fitness | Vo2 max measured via a maximal exercise test on a treadmill | Change from baseline to after surgery (12 weeks) |
| Quality of life (SF-36) | 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) | Change from baseline to after surgery (12 weeks) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |