Recombinant Human Leptin Therapy Effects on Insulin Action
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.
研究概览
简要总结
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.
详细描述
Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with type 2 diabetes for less than ten years
- •Body mass index 25 - 40
- •hemoglobin A1C 7.5% - 12.0%
- •fasting blood glucose between 90 and 240mg/dL
排除标准
- •pregnancy
- •diabetes medications
- •regular exercise (more than 3 hours per week)
- •uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95
研究组 & 干预措施
placebo
saline placebo for fourteen days
干预措施: placebo (Dietary Supplement)
low-dose leptin
30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
干预措施: low-dose leptin (Drug)
high-dose leptin
80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
干预措施: high-dose leptin (Drug)
结局指标
主要结局
Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.
时间窗: fourteen days
This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.
时间窗: baseline
pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.
次要结局
- Post-treatment Plasma Leptin Levels(fourteen days)
- Baseline Plasma Leptin Concentrations(baseline)