Metabolic Adaptations to Weight Loss With and Without Exercise

Obesity Clinical Trial

— WAX  

Official title:

Metabolic Adaptations to Weight Loss With and Without Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806801
• Other study ID #: HUM00220220
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2023
• Est. completion date: May 31, 2028

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Suzette M Howton
• Phone: 734-647-9850
• Email: suzetter[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 31, 2028
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance
• Insulin Sensitivity
• Metabolic Disease
• Metabolic Diseases
• Metabolic Syndrome
• Obesity
• Weight Loss

Intervention

Behavioral:
• MICT Exercise
Subjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week.
• No Exercise (Control)
Subjects randomized into this group will remain sedentary throughout the duration of the study.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	a hyperinsulinemic-euglycemic clamp will be used to quantify peripheral insulin sensitivity	2 hours
Primary	Fatty acid turnover	stable isotope tracer infusion methods will be used to assess fatty acid turnover	2 hours
Primary	Adipose tissue capillarization	measured immunohistochemically using an antibody for CD31, quantified using ImageJ software	30 minutes
Primary	Adipose tissue fibrosis	measured histologically using Sirus Red Staining, quantified using ImageJ software	30 minutes
Secondary	Body weight change	Change in body weight will be assessed 6 months after completing the 10% weight loss intervention	6 months
Secondary	Body fat mass	Body fat mass will be measured by Dual Energy X-ray Absorptiometry (DEXA)	30 minutes
Secondary	Oral Glucose Tolerance Test (OGTT)	A test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood will be completed at each clinical visit appointment	2 hours