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 range18 Years – 45 Years
SexALL
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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…
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