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Epigenetic Regulation of Adipose Tissue Distribution in Obesity (Eiffel 2 Trial)

N/A
Waitlist Available
Led By Steven R Smith, MD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trialstudies how men and women store fat differently and looks to improve our understanding of the issue. #fitness #health

Who is the study for?
This trial is for men and women aged 18-45 with a BMI of 23-35, stable weight in the last three months, non-smokers, not pregnant or postpartum beyond nine months. Excluded are those with serious health conditions like uncontrolled hypertension, kidney/liver disease, recent heart attacks or cancer, untreated thyroid issues or certain mental illnesses.Check my eligibility
What is being tested?
Researchers are studying how adults store fat differently by using tests like FSIGTT/RMR to measure insulin sensitivity and metabolism; DEXA/MRI/MRS scans to visualize body composition; and adipose tissue biopsies to examine fat distribution at a cellular level.See study design
What are the potential side effects?
There may be minimal side effects from the study procedures such as discomfort at biopsy sites, potential reactions to MRI contrast agents if used (rare), and typical risks associated with X-rays during DEXA scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes

Trial Design

3Treatment groups
Active Control
Group I: Group A- Women- Healthy 'pears'Active Control3 Interventions
This group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.78 or less.
Group II: Group B- Women- Healthy 'apples'Active Control3 Interventions
The group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.85 or more.
Group III: Group C- Men- Healthy 'apples'Active Control3 Interventions
The group will consist of men with a BMI between 23 and 35 kg/m2.

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,594 Total Patients Enrolled
11 Trials studying Obesity
342 Patients Enrolled for Obesity
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
5,601 Total Patients Enrolled
11 Trials studying Obesity
342 Patients Enrolled for Obesity
Sanford-Burnham Medical Research InstituteOTHER
8 Previous Clinical Trials
594 Total Patients Enrolled
3 Trials studying Obesity
63 Patients Enrolled for Obesity

Media Library

Group A- Women- Healthy 'pears' Clinical Trial Eligibility Overview. Trial Name: NCT02728635 — N/A
Obesity Research Study Groups: Group A- Women- Healthy 'pears', Group B- Women- Healthy 'apples', Group C- Men- Healthy 'apples'
Obesity Clinical Trial 2023: Group A- Women- Healthy 'pears' Highlights & Side Effects. Trial Name: NCT02728635 — N/A
Group A- Women- Healthy 'pears' 2023 Treatment Timeline for Medical Study. Trial Name: NCT02728635 — N/A
~1 spots leftby Dec 2024