Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women (Apple/Pear)

Pennington Biomedical Research Center

Status

Completed

Conditions

Obesity

Metabolic Syndrome

Treatments

Drug: Pioglitazone

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01748994

PBRC 10039

5R01DK090607 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Adipose tissue expandability and the distribution of stored fat in the body are stronger predictors of health risk. A better understanding of the factors that determine regional fat mass growth may lead to developing new strategies for prevention or treatment of metabolic complications of obesity. The objective of this proposal is to study the responsiveness of different fat depots to adipogenic stimulation in upper-body and lower-body obese women.

Enrollment

63 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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)