Exercise Training Study Before Bariatric Surgery

NCT06274606 | Withdrawn

• 1 other identifier: HSR230106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Obesity; Insulin sensitivity; Exercise intervention

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp

  Change from baseline to after surgery (12 weeks)

Secondary Outcomes (19)

• Surgical outcomes - readmission within 30 days of surgery

  within 30 days

• Surgical outcomes - IV treatment as an outpatient

  Change from baseline to after surgery (12 weeks)

• Surgical outcomes - emergency department visits

  Change from baseline to after surgery (12 weeks)

• Surgical outcomes - time of surgery

  Intraoperative

• Surgical outcomes - length of stay after surgery completion

  Change from baseline to after surgery (12 weeks)

Study Arms (2)

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.

Other: Exercise Group

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.

Interventions

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

Exercise Group (EX-group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 23, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 15, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 1 year of study completion
• Access Criteria: Access to UVA Health portals, including UVA Health REDCap

Locations

US (1)