Epigenetic Regulation of Human Adipose Tissue Distribution



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:2/17/2019
Start Date:July 2016
End Date:December 2020

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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).


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 EKG.

- Current smokers (smoking within the past 3 months).

- 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 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.

- 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.
We found this trial at
1
site
Orlando, Florida 32804
Principal Investigator: Steven R Smith, MD
Phone: 407-303-7100
?
mi
from
Orlando, FL
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