NCT02459106已完成不适用
Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2015年5月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Levels of miRNA will be measured as well as the adipose tissue specific miRNA.
研究概览
简要总结
The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. This information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.
详细描述
Study Objectives:
- To establish and optimize the methodology for measuring adipose tissue miRNA release.
- To establish and optimize the methodology for measuring the effect of adipose tissue-released miRNA on skeletal muscle biology and insulin sensitivity.
- To profile adipose tissue-released miRNA in lean insulin-sensitive and obese insulin-resistant healthy individuals.
- To examine the effects of adipose tissue-released miRNA from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- •18-65 years of age
- •BMI of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
- •Stable body weight (< 3 kg change in the last 8 weeks)
- •homeostatic model assessment (HOMA)-insulin resistance <2.7 if lean; homeostatic model assessment (HOMA)-insulin resistance ≥2.7 if obese
排除标准
- •Lactation or pregnancy, current and/or within last 6 months, per participant's report
- •Female subjects postmenopausal
- •Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
- •Liver disease (AST or ALT(alanine aminotransferase)>2.5 times the upper limit of normal)
- •Kidney disease (creatinine >1.6 mg/dl)
- •Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
- •Thyroid dysfunction (abnormal TSH)
- •HbA1c ≥6.5%
- •Uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
- •History of coagulopathies
- •History (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
- •Current or history of drug abuse or alcohol abuse (>2 drinks/day)
- •Prior treatment (within last 3 months) with systemic glucocorticoids (>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
- •History of HIV, active Hepatitis B or C, or Tuberculosis (participant reported)
- •Smoke > 5 cigarettes per day
结局指标
主要结局
Levels of miRNA will be measured as well as the adipose tissue specific miRNA.
时间窗: 4 weeks
The effect of miRNA released by adipose tissue from lean insulin-sensitive and from obese insulin-resistant individuals on skeletal muscle biology and insulin signaling.
次要结局
未报告次要终点
研究者
研究点 (1)
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