Epigenetic Regulation of Human Adipose Tissue Distribution
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes
研究概览
简要总结
The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years inclusive;
- •BMI 23-35 kg/m2 inclusive;
- •HbA1C <6.0%;
- •Weight stable (± 3 kg) during the 3 months prior to enrollment;
- •Women must be > 9 months post-partum;
- •Able to provide written, informed consent.
排除标准
- •Postmenopausal women
- •Women with an oophorectomy
- •Fasting plasma glucose > 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
- •Untreated or symptomatic thyroid disease.
- •Aminotransferase or aspartate aminotransferase > 3x upper limit of laboratory reference range, or known diagnosis of liver disease.
- •Creatinine > 2x upper limit of laboratory reference range, or known diagnosis of kidney disease.
- •Uncontrolled hypertension (BP > 140 systolic or > 90 diastolic)
- •New onset (<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.
- •History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. Current drug use may be determine by plasma or urine drug screens.
- •History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
- •History of organ transplant.
- •Myocardial Infarction within the last 6 months.
- •Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
- •History of HIV, active Hepatitis B or C or tuberculosis
- •Presence of clinically significant abnormalities on EKG.
- •Current smokers (smoking within the past 3 months).
- •Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids [steroids], etc.)
- •Other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical
- •Other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc.
- •Elevated high sensitivity c-reactive protein or known active infection.
- •There are some implants which are MR compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.
结局指标
主要结局
Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes
时间窗: 6 weeks
The preadipocytes obtained from biopsies of Abdominal Fat and Gluteofemoral Fat from patients in the 'pears' woman, 'apple' women and men will be cultured by our standard methods in proliferative medium followed by our standard protocol for differentiation into mature adipocytes. We propose to evaluate samples from 3 individuals from each Group to identify a large number of differentially regulated regions genome wide. All the data obtained in vitro in culture cells will be compared with the data obtained from RNA and chromatin isolated from the whole tissue Abdominal fat and Gluteofemoral fat biopsies
次要结局
未报告次要终点