NCT02728635Active, not recruiting
Epigenetic Regulation of Human Adipose Tissue Distribution
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 24 Mar 2016
- Start date
- 1 Jul 2016
- Primary completion date
- 11 Jul 2018
- Lead sponsor
- AdventHealth Translational Research Institute
- Diseases
- Obesity
- NCT number
- NCT02728635
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 1 Jul 2016 to the primary completion date, 11 Jul 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- New onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.
- Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
- There are some implants which are MR compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.
Other illness
- Untreated or symptomatic thyroid disease.
- Uncontrolled hypertension (BP \> 140 systolic or \> 90 diastolic)
- 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.
- History of HIV, active Hepatitis B or C or tuberculosis
- Other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical
- Other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc.
- Elevated high sensitivity c-reactive protein or known active infection.
Lab values
- Fasting plasma glucose \> 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
- 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.
- Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids \[steroids\], etc.)
Other
- Postmenopausal women
- Women with an oophorectomy
- Presence of clinically significant abnormalities on EKG.
- Current smokers (smoking within the past 3 months).
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.