NCT01581736终止1 期
Molecular Regulation of Muscle Glucose Metabolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- insulin sensitivity
研究概览
简要总结
This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.
详细描述
This protocol involves performance of a hyperinsulinemic euglycemic clamp with 2 muscle biopsies and an exercise study with a muscle biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- •Subjects may be of either sex, age as described in each protocol. Female subjects must be non-lactating and must either be at least two years post-menopausal, (if diabetic or obese) or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients (except for those patients who have undergone a hysterectomy or bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
- •Subjects must range in age as described in each specific protocol.
- •All nondiabetic subjects must have normal oral glucose tolerance.
- •Subjects must have the following laboratory values:
- •Hematocrit ≥ 35 vol%
- •Serum creatinine ≤ 1.6 mg/dl
- •Aspartate aminotransferase (AST) (SGOT) < 2 times upper limit of normal
- •Alanine aminotransferase (ALT) (SGPT) < 2 times upper limit of normal
- •Alkaline phosphatase < 2 times upper limit of normal
- •Triglycerides < 150 mg/dl.
- •Prothrombin time (PT) 11.7 -14.3 (During Liposyn/heparin infusion, PT will be determined to insure that it is < 1.5-2.0 times the normal value.)
- •Partial thromboplastin time (PTT) 23.0-37.0.
排除标准
- •Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded.
- •Subjects with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
- •Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP > 180, diastolic BP > 105, autonomic neuropathy, resting heart rate > 100, electrolyte abnormalities.
研究组 & 干预措施
Exercise
Experimental
Proteomics of muscle after a single bout of exercise compared to baseline with U100 Humulin infusion at rate of 80 milliunits(mU)/m^2 surface area.
干预措施: U100 Humulin (Drug)
Exercise
Experimental
Proteomics of muscle after a single bout of exercise compared to baseline with U100 Humulin infusion at rate of 80 milliunits(mU)/m^2 surface area.
干预措施: Exercise (Other)
结局指标
主要结局
insulin sensitivity
时间窗: one month from date of volunteer study
euglycemic clamp
次要结局
- acetylation of mitochondrial adenine nucleotide translocase(within 6 months of volunteer study)
研究者
Lori R. Roust
Consultant in Endocrinology
Mayo Clinic
研究点 (1)
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