WithdrawnNot Applicable

Exercise Training Study Before Bariatric Surgery

Stopped: Project during development was discontinued before the enrollment of participants

United States0Started 2024-07-01

Plain-language 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

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 contraindic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insulin sensitivity

Timeframe: Change from baseline to after surgery (12 weeks)

Trial details

NCT IDNCT06274606

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Bariatric Surgery Candidate trials