Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- In Vivo Adipose Cell Formation (Adipogenesis)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Placebo
Administration of placebo to upper- and lower-body obese women
干预措施: Placebo (Drug)
Drug
Administration of pioglitazone to upper- and lower-body obese women
干预措施: Pioglitazone (Drug)
结局指标
主要结局
In Vivo Adipose Cell Formation (Adipogenesis)
时间窗: Change from baseline in adipogenesis at 16 weeks
Following the consumption of water labeled with the stable isotope deuterium (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral (thigh) depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation, or adipogenesis. The primary outcome is to assess the change (from baseline) in adipose cell formation rates (i.e. adipogenesis) in response to 16-weeks of pioglitazone versus the control group.
次要结局
- Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue)(Change from baseline in visceral fat at 16 weeks)
- Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL)(Change from Baseline in intra-hepato-cellular lipid at 16 weeks)
- Matsuda Index (Measure of Insulin Sensitivity)(Change from Baseline in Matsuda Index at 16 weeks)
研究者
Eric Ravussin
Principal Investigator
Pennington Biomedical Research Center