Exploring the Incretin Effect in People With IFG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Insulin Secretion
研究概览
简要总结
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose <5.6 mmol/l and 2h OGTT <7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT <7.8 mmol/l).
排除标准
- •Subjects were excluded for: thyroid stimulating hormone <50 or >500 milliunits/L, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2 times normal), hematocrit < 38%, or white blood cell count <3.0 x
- •Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI <25 or >40 kg/m
- •Diabetes or impaired glucose tolerance.
研究组 & 干预措施
Impaired Fasting Glucose
Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate)
干预措施: Sitagliptin Phosphate (Drug)
Normal glucose tolerance
Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)
干预措施: Sitagliptin Phosphate (Drug)
结局指标
主要结局
Change in Insulin Secretion
时间窗: Baseline and 28 days
Change in Endogenous Glucose Production
时间窗: Baseline and 28 days
次要结局
- Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1(Baseline and 28 days)
- Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon(Baseline and 28 days)
- Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide(Baseline and 28 days)
- Insulin Secretion in Response to Oral vs. IV Glucose(Baseline)
- Baseline and Change in Hormones, Substrates and Insulin Action: Lactate(Baseline and 28 days)
- Baseline and Change in Hormones, Substrates and Insulin Action: FFA(Baseline and 28 days)
- Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol(Baseline and 28 days)