Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Metabolic Syndrome

In brief

The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Since "pear" shaped women tend to have better health, this study will open the door to future research in regulating body shape and thus improving health.

Key facts

Study ID

NCT01748994

Run by

Pennington Biomedical Research Center

People needed

63

Starts

2011-02-01

Expected to finish

2016-12-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• You are a pre-menopausal woman between 18-40 years of age
• Your Body Mass Index (BMI, weight-to-height2 ratio) is 27 - 38 kg/m2, inclusive
• The ratio of your waist-to-hip circumferences is either >0.84 ("apple"-type body shape) or <0.77 ("pear"-type body shape)
• You are willing to undergo a drug intervention for 16 weeks
• You are willing to drink heavy water [similar to the ordinary water that is highly enriched in the naturally occurring stable (non-radioactive) form of hydrogen, deuterium; also called deuterium-labeled water] for 8 weeks before the beginning and during the second half of the drug intervention; you will need 24-hours access to a refrigerator for storage of the water.
• You agree to use a double barrier method as a form of birth control to prevent pregnancy. Oral contraceptives (birth control pills) are not allowed in the study. Acceptable methods of birth control are condoms, spermicide, IUD (intrauterine device, must be hormone free - see list in clinic), diaphragm and abstinence. An example of a double barrier method would be condoms plus spermicide, etc.

You may not qualify if…

• You have gained or lost more than 4.5 lb (2 kg) in the last 3 months
• You have had significant changes in the diet or level of physical activity within the past month
• You have a blood sugar of greater than 100 or a diagnosis of diabetes.
• You have abnormal liver enzyme values from your blood work
• You have a history of heart, kidney, lung, liver, and thyroid disease
• You have an average blood pressure >140/90 at your screening visit
• Have you had a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C?
• You require chronic use of medications including diuretics, steroids, thyroid hormones, and adrenergic-stimulating agents (bronchodilators, nasal decongestants)

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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