Epigenetic Regulation of Human Adipose Tissue Distribution (NCT02728635) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Epigenetic Regulation of Human Adipose Tissue Distribution
United States27 participantsStarted 2016-07
Plain-language summary
The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-45 years inclusive;
* BMI 23-35 kg/m2 inclusive;
* HbA1C \<6.0%;
* Weight stable (± 3 kg) during the 3 months prior to enrollment;
* Women must be \> 9 months post-partum;
* Able to provide written, informed consent.
Exclusion Criteria:
* Postmenopausal women
* Women with an oophorectomy
* Fasting plasma glucose \> 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
* Untreated or symptomatic thyroid disease.
* Aminotransferase or aspartate aminotransferase \> 3x upper limit of laboratory reference range, or known diagnosis of liver disease.
* Creatinine \> 2x upper limit of laboratory reference range, or known diagnosis of kidney disease.
* Uncontrolled hypertension (BP \> 140 systolic or \> 90 diastolic)
* New onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.
* History of drug or alcohol abuse (\> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. Current drug use may be determine by plasma or urine drug screens.
* History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
* History of organ transplant.
* Myocardial Infarction within the last 6 months.
* Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
* History of HIV, active Hepatitis B or C or tuberculosis
* Presence of clinically significant abnormalities on…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes
Timeframe: 6 weeks
Trial details
NCT IDNCT02728635
SponsorAdventHealth Translational Research Institute