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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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received an organ transplant in the past.You have a history of heavy drug or alcohol use in the past 5 years, or a mental health condition that would make it hard for you to follow the study rules. We may check for drugs in your blood or urine.You had any type of cancer, except non-melanoma skin cancer, within the past 5 years.You have another health condition that could impact the study results, according to the doctor's opinion.You have been smoking within the last 3 months.You have a thyroid disease that is not being treated or is causing noticeable symptoms.You have a condition that could increase the risk of complications during the procedure, such as a bleeding disorder or claustrophobia.Your body mass index (BMI) falls between 23 and 35, which means you are within a healthy weight range.If you have certain implants that are safe for MRI, but could make it difficult for us to accurately measure an organ, like braces that cover your whole mouth that may affect our ability to measure your brain size, you may not be eligible for the study.You have used medications in the past 3 months that can affect your glucose, fat, or energy levels, like growth hormone therapy or steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Group A- Women- Healthy 'pears'
- Group 2: Group B- Women- Healthy 'apples'
- Group 3: Group C- Men- Healthy 'apples'
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.
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