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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
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 belowSelect...
I am between 18 and 40 years old.
Select...
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:Select...
I have a history of heart disease, diabetes, or another metabolic condition.
Select...
I am not allergic to Lidocaine and do not take blood thinners like Coumadin.
Select...
I am not on medication that affects my cholesterol or blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreSecondary study objectives
Body fat mass
Body weight change
Oral Glucose Tolerance Test (OGTT)
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
1,833 Previous Clinical Trials
6,423,060 Total Patients Enrolled
Jeffrey Horowitz, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You use tobacco or e-cigarettes.I am between 18 and 40 years old.You have had a bad reaction to insulin, human albumin, or potassium chloride injections before.Your body mass index (BMI) is between 30 and 40.You do not regularly engage in exercise or physical activity.I have a history of heart disease, diabetes, or another metabolic condition.You are allergic to certain types of local anesthetics, like lidocaine.I have had high potassium levels or take medication that could cause this.I am not allergic to Lidocaine and do not take blood thinners like Coumadin.You have abnormalities in your heart's electrical activity, as shown on an EKG test.I am a woman who has regular periods and am not in menopause.I am not on medication that affects my cholesterol or blood sugar levels.My weight has been stable for at least 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate Intensity Continuous Training (MICT) exercise group
- Group 2: No exercise (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Insulin Sensitivity Patient Testimony for trial: Trial Name: NCT05806801 — N/A
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