NCT03452267撤回2 期
Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proteomic
研究概览
简要总结
The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
- •General Inclusion Criteria:
- •Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
- •Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
排除标准
- •Oral glucose tolerance test <140 or >200mg/dL
- •Treated with any of the following medications:
- •Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
- •Start or change of hormonal replacement therapy within 3 months prior to screening
- •Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
- •History or presence of any of the following conditions:
- •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)
- •Clinically significant pulmonary disease.
- •Current uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
- •History or presence of malignancy other than basal cell or squamous cell skin cancer
- •Autonomic neuropathy
- •Clinically significant hematologic disease
- •Any of the following abnormal laboratory values:
- •Hematocrit < 35 vol%
- •Serum creatinine > 1.6 mg/dl
- •AST, ALT or Alkaline phosphatase > 2.5 times the upper limit of normal
- •PT, PTT outside the normal reference range
- •TSH outside the normal reference range
- •Triglycerides > 400 mg/dl
- •Platelet count < 50,000
- •Current or history of drug abuse or alcohol abuse
- •Blood donation within 2 months prior to screening
- •Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
- •Diagnosed with Type 1 diabetes
研究组 & 干预措施
Metformin
Experimental
干预措施: Metformin (Drug)
Pioglitazone
Experimental
干预措施: Pioglitazone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proteomic
时间窗: 3 months
Changes in global protein abundance levels
Proteomic 2
时间窗: 3 months
Changes in global protein phosphorylation levels
次要结局
- Epigenomic(3 months)
研究者
Kyle Jon Burghardt, Pharm.D.
Assistant Professor of Pharmacy Practice
Wayne State University
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