Exercise Training Study Before Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— BaSE  

Official title:

Exercise Training Study Before Bariatric Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06274606
• Other study ID #: HSR230106
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: June 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Other:
• Exercise 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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp	Change from baseline to after surgery (12 weeks)
Secondary	Surgical outcomes - readmission within 30 days of surgery	Variables recorded after surgery such as readmission within 30 days of surgery	within 30 days
Secondary	Surgical outcomes - IV treatment as an outpatient	Variables recorded after surgery such as IV treatment as an outpatient	Change from baseline to after surgery (12 weeks)
Secondary	Surgical outcomes - emergency department visits	Variables recorded after surgery such as emergency department visits	Change from baseline to after surgery (12 weeks)
Secondary	Surgical outcomes - time of surgery	Variables recorded after surgery such as time of surgery (min).	Intraoperative
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Body fat	Dual-energy x-ray absorptiometry (DEXA) will be used to access body fat (g)	Change from baseline to after surgery (12 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Plasma glucose	Plasma glucose (mg/dL) from intravenous line	Change from baseline to after surgery (12 weeks)
Secondary	Plasma insulin	Plasma insulin (uIU/dL) from intravenous line	Change from baseline to after surgery (12 weeks)
Secondary	Hemoglobin A1c	Hemoglobin A1C (%) - an average of blood glucose levels in the previous 3 months	up to 12 weeks
Secondary	Cardiorespiratory fitness	Vo2 max measured via a maximal exercise test on a treadmill	Change from baseline to after surgery (12 weeks)
Secondary	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)