Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Administration of placebo to upper- and lower-body obese women

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug

Administration of pioglitazone to upper- and lower-body obese women

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

30mg per day for four months

Interventions

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Pioglitazone

30mg per day for four months

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes