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Exercise for Obesity Management (LG Trial)

N/A

Recruiting

Led By Jeffrey F Horowitz, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women must have regularly occurring menses and must be premenopausal

Age: 18-40

Must not have

Women must not be pregnant or actively lactating

Evidence/history of cardiovascular or metabolic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether exercise helps people keep weight off after they lose it.

Who is the study for?

This trial is for adults aged 18-40 with a BMI of 27-45 who haven't been exercising regularly. Women should have regular menstrual cycles and not be pregnant or breastfeeding. People can't join if they've had heart or metabolic diseases, take meds affecting metabolism, had recent weight fluctuations, or use tobacco products.

What is being tested?

The study is testing the impact of exercise on body fat and how it functions after weight loss. Participants will either follow an exercise program or no exercise while losing and then regaining weight. Their metabolic health will be tested before and after these changes.

What are the potential side effects?

Since this trial involves standard physical activity as the intervention, side effects may include typical exercise-related issues such as muscle soreness, fatigue, or injury. The high-calorie diet phase could potentially lead to temporary weight gain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who has regular menstrual cycles and am not in menopause.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a history of heart or metabolic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adipose Capillarization

Adipose Tissue Fibrosis

Fat Cell Size

+2 more

Secondary study objectives

Blood Lipid Profile

Blood Pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No exerciseExperimental Treatment1 Intervention

Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.

Group II: ExerciseExperimental Treatment1 Intervention

This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

No exercise

2021

Completed Phase 4

~570

Exercise

2016

Completed Phase 1

~820