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Exercise for Weight Loss (WAX Trial)

N/A
Recruiting
Led By Jeffrey 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
Age: 18-40
Women must have regularly occurring menses and must be premenopausal
Must not have
Evidence/history of cardiovascular disease, diabetes or other metabolic disease
Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating how weight loss & exercise together affect abdominal fat tissue & potential health benefits. Involvement is 10-13 months.

Who is the study for?
This trial is for premenopausal women aged 18-40 with a BMI of 30-40, who have stable weight and don't regularly exercise. It's not for those pregnant, lactating, with heart disease or metabolic diseases like diabetes, on certain medications affecting metabolism, using tobacco products, or with allergies to specific drugs.
What is being tested?
The study tests how adding moderate intensity continuous training (MICT) exercise affects fat tissue and metabolic health during a weight loss program compared to no exercise. Participants will undergo metabolic testing before, during and after achieving a 10% weight loss.
What are the potential side effects?
Since the interventions involve diet control and MICT exercises like walking or cycling at a steady pace, side effects may include typical physical activity-related issues such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.
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I am a woman who has regular periods and am not in menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart disease, diabetes, or another metabolic condition.
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I am not allergic to Lidocaine and do not take blood thinners like Coumadin.
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I am not on medication that affects my cholesterol or blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 tissue capillarization
Adipose tissue fibrosis
Fatty acid turnover
+1 more
Secondary study objectives
Body fat mass
Body weight change
Oral Glucose Tolerance Test (OGTT)

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 exercise (Control)Experimental Treatment1 Intervention
to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study
Group II: Moderate Intensity Continuous Training (MICT) exercise groupExperimental Treatment1 Intervention
45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,854 Previous Clinical Trials
6,433,493 Total Patients Enrolled
35 Trials studying Obesity
9,984 Patients Enrolled for Obesity
Jeffrey Horowitz, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

MICT Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05806801 — N/A
Obesity Research Study Groups: Moderate Intensity Continuous Training (MICT) exercise group, No exercise (Control)
Obesity Clinical Trial 2023: MICT Exercise Highlights & Side Effects. Trial Name: NCT05806801 — N/A
MICT Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05806801 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT05806801 — N/A
~45 spots leftby Aug 2027
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