N/A N=63 Randomized Single-blind Basic Science

Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women

Obesity · Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01748994 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: In Vivo Adipose Cell Formation (Adipogenesis) — -0.3; 1.8; -1.2; 2.1 percent

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pioglitazone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Pennington Biomedical Research Center
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY In Vivo Adipose Cell Formation (Adipogenesis)	-0.3; 1.8; -1.2; 2.1	—
SECONDARY Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue)	0.5; -0.8	—
SECONDARY Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL)	-0.7; -2.0	—
SECONDARY Matsuda Index (Measure of Insulin Sensitivity)	-0.39; 0.80	—

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.

Eligibility Criteria

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 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)

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Data sourced from ClinicalTrials.gov (NCT01748994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.