Exercise Effects on Adipose Tissue Structure and Function

Obesity Clinical Trial

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Official title:

Exercise Effects on Adipose Tissue Structure and Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812314
• Other study ID #: HUM00175528
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2030

Study information

• Verified date: June 2023
• Source: University of Michigan
• Contact: Suzette Howton
• Phone: 734-647-9850
• Email: smlstudies[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

Description:

Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases. Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain). Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 1, 2030
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age: 18-40
• Body Mass Index: 27-45 kg/m2
• No regularly planned exercise/physical activity for at least 6 months
• Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

• Evidence/history of cardiovascular or metabolic disease
• Medications known to affect lipid or glucose metabolism, or inflammation
• Weight instability = ± 6 pounds in the last 3 months
• Tobacco or e-cigarette users
• Women must not be pregnant or actively lactating

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Exercise
Participants will complete a moderate intensity continuous exercise 4 days/week.
• No exercise
Participants 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	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
Primary	Adipose Tissue Fibrosis	measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.	30 minutes
Primary	Muscle Capillarization	measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.	30 minutes
Primary	Adipose Capillarization	measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.	30 minutes
Primary	Fat Cell Size	measured histologically using Hematoxylin and eosin (H & E) staining, quantified using ImageJ software at each clinical visit appointment.	3 minutes
Secondary	Blood Lipid Profile	A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.	15 minutes
Secondary	Blood Pressure	The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.	10 minutes