Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in insulin resistance (IR) from baseline to 13 weeks
研究概览
简要总结
Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20 year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c 7.0%-9.9%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).
排除标准
- •Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit <30% or hemoglobin <10 gm/dL
研究组 & 干预措施
Oral Placebo
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
- Micosolle™, silica based excipient
- Silicified Micro Crystalline Cellulose, National Formulary
- Safflower Oil, United States Pharmacopeia
- K-30 Povidone Powder
- Magnesium Stearate, National Formulary (Vegetable source)
- Fumed Silica, National Formulary
干预措施: Placebo (Drug)
Metformin
Metformin 2000 mg per day
干预措施: Metformin (Drug)
结局指标
主要结局
Change in insulin resistance (IR) from baseline to 13 weeks
时间窗: 0-13 weeks
Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).
次要结局
- Change in Hepatic IR from baseline to 13 weeks(0-13 weeks)
- Change in Adipose IR from baseline to 13 weeks(0-13 weeks)