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Clinical Trials/NCT05806801
NCT05806801
Recruiting
Not Applicable

Metabolic Adaptations to Weight Loss With and Without Exercise

University of Michigan1 site in 1 country68 target enrollmentJuly 19, 2023

Overview

Phase
Not Applicable
Intervention
MICT Exercise
Conditions
Obesity
Sponsor
University of Michigan
Enrollment
68
Locations
1
Primary Endpoint
Adipose tissue fibrosis
Status
Recruiting
Last Updated
18 days ago

Overview

Brief Summary

Study Purpose:

The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.

Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained

Study Summary:

10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:

  1. Moderate Intensity Continuous Training (MICT) exercise group
  2. No exercise (control) group

Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.

Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).

Registry
clinicaltrials.gov
Start Date
July 19, 2023
End Date
May 31, 2028
Last Updated
18 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey F Horowitz

Professor of Movement Science and Director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Age: 18-40
  • Body Mass Index: 30-40 kg/m2
  • Weight stable (±3kg for greater than or equal to about 2 months)
  • No regularly planned exercise/physical activity
  • Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria

  • EKG abnormalities
  • Evidence/history of cardiovascular disease, diabetes or other metabolic disease
  • Medications known to affect lipid or glucose metabolism
  • Pregnant or lactating
  • Tobacco or e-cigarette use
  • Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.
  • Allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine)
  • History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)
  • Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.

Arms & Interventions

Moderate Intensity Continuous Training (MICT) exercise group

45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study

Intervention: MICT Exercise

No exercise (Control)

to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study

Intervention: No Exercise (Control)

Outcomes

Primary Outcomes

Adipose tissue fibrosis

Time Frame: 30 minutes

measured histologically using Sirus Red Staining, quantified using ImageJ software

Insulin sensitivity

Time Frame: 2 hours

a hyperinsulinemic-euglycemic clamp will be used to quantify peripheral insulin sensitivity

Fatty acid turnover

Time Frame: 2 hours

stable isotope tracer infusion methods will be used to assess fatty acid turnover

Adipose tissue capillarization

Time Frame: 30 minutes

measured immunohistochemically using an antibody for CD31, quantified using ImageJ software

Secondary Outcomes

  • Body weight change(6 months)
  • Body fat mass(30 minutes)
  • Oral Glucose Tolerance Test (OGTT)(2 hours)

Study Sites (1)

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