Exercise Training Study Before Bariatric Surgery (BaSE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Other: Exercise Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damon L Swift; Phone Number: (434) 924-1436; Email: dls3s@virginia.edu
• Study Contact Backup: Name: Emily Grammer; Phone Number: 8508968401; Email: erk9nk@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • University of Virginia
      • Contact: Damon L Swift, PhD; Phone Number: 434-924-1436; Email: dls3s@virginia.edu
      • Contact: Emily E Grammer, MS; Phone Number: 8508968401; Email: erk9nk@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group (EX-group); 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; 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
No Intervention: Standard Care Only Group (SC-group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp	Change from baseline to after surgery (12 weeks)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Insulin sensitivity; Exercise intervention
• Other Study ID Numbers: HSR230106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication.
• IPD Sharing Time Frame: Within 1 year of study completion
• IPD Sharing Access Criteria: Access to UVA Health portals, including UVA Health REDCap
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No