Overview

This trial is active, not recruiting.

Conditions obesity, metabolic syndrome
Treatments pioglitazone, placebo
Sponsor Pennington Biomedical Research Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date February 2011
End date December 2016
Trial size 40 participants
Trial identifier NCT01748994, 5R01DK090607, PBRC 10039

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Placebo Comparator)
Administration of placebo to upper- and lower-body obese women
placebo
(Active Comparator)
Administration of pioglitazone to upper- and lower-body obese women
pioglitazone Actos
30mg per day for four months

Primary Outcomes

Measure
Enrichment of DNA of adipose cells with deuterium
time frame: Change from Baseline in Enrichment of DNA of adipose cells with deuterium at 4 Months

Secondary Outcomes

Measure
Differentiation of adipose-derived stromo-vascular cultures
time frame: Change from Baseline inDifferentiation of adipose-derived stromo-vascular cultures at 4 Months
Proliferation of adipose-derived stromo-vascular cultures
time frame: Change from Baseline in Proliferation of adipose-derived stromo-vascular cultures at 4 Months
Apoptosis of adipose-derived stromo-vascular cultures
time frame: Change from Baseline in Apoptosis of adipose-derived stromo-vascular cultures at 4 Months
Size of adipocytes
time frame: Change from Baseline in Size of adipocytes at 4 Months
Number of fat cells
time frame: Change from Baseline in Number of fat cells at 4 Months
Number of fat cell precursor cells
time frame: Change from Baseline in Number of fat cell precursor cells at 4 Months
Body composition
time frame: Change from Baseline in Body composition at 4 Months
Volume of abdominal fat depots
time frame: Change from Baseline in Volume of abdominal fat depots at 4 Months
Lipid accretion in the skeletal muscle cells (intra-myo-cellular lipid)
time frame: Change from Baseline in intra-myo-cellular lipid at 4 Months
Lipid accretion in the cells of the liver (intra-hepato-cellular lipid)
time frame: Change from Baseline in intra-hepato-cellular lipid at 4 Months
Proinflammatory state of adipose-derived stromo-vascular cultures
time frame: Change from Baseline in Proinflammatory state of adipose-derived stromo-vascular cultures at 4 Months
Glucose tolerance
time frame: Change from Baseline in Glucose tolerance at 4 Months

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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)

Additional Information

Official title Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pennington Biomedical Research Center.