Epigenetic Regulation of Human Adipose Tissue Distribution (Eiffel 2)

AdventHealth Translational Research Institute

Status: Active, not recruiting

Conditions: Obesity

Treatments: Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS); Other: FSIGTT/ RMR; Procedure: Adipose tissue biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT02728635

TRIMDFH 869496

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Group A- Women- Healthy 'pears'

Active Comparator group

Description:

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.

Treatment:

Procedure: Adipose tissue biopsies

Other: FSIGTT/ RMR

Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)

Group B- Women- Healthy 'apples'

Active Comparator group

Description:

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.

Treatment:

Procedure: Adipose tissue biopsies

Other: FSIGTT/ RMR

Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)

Group C- Men- Healthy 'apples'

Active Comparator group

Description:

The group will consist of men with a BMI between 23 and 35 kg/m2.

Treatment:

Procedure: Adipose tissue biopsies

Other: FSIGTT/ RMR

Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)