Clinical trial NCT06274606: Exercise Training Study Before Bariatric Surgery
Official title: Exercise Training Study Before Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric surgery
Obesity
Insulin sensitivity
Exercise intervention
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Change from baseline to after surgery (12 weeks)
Secondary outcomes:
measure: Surgical outcomes - readmission within 30 days of surgery
timeFrame: within 30 days
measure: Surgical outcomes - IV treatment as an outpatient
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Surgical outcomes - emergency department visits
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Surgical outcomes - time of surgery
timeFrame: Intraoperative
measure: Surgical outcomes - length of stay after surgery completion
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Flow-mediated dilation (FMD)
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Pulse-wave analysis (PWA)
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Pulse-wave velocity (PWV)
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Body fat
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Lean body mass
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Bone mineral density
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Visceral adiposity
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Weight
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Blood Lipids
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Plasma glucose
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Plasma insulin
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Hemoglobin A1c
timeFrame: up to 12 weeks
measure: Cardiorespiratory fitness
timeFrame: Change from baseline to after surgery (12 weeks)
measure: Quality of life (SF-36)
timeFrame: Change from baseline to after surgery (12 weeks)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: