Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
研究概览
简要总结
The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose
详细描述
The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.
From this, we will evaluate GIP's role as blood sugar stabilizer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
- •Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
- •Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
- •Normal hemoglobin
- •Informed consent
- •Exclusion criteria:
- •Unwillingness to participate or the wish to leave the present study
- •HbA1c > 9 %
- •Liver disease (ALAT or ASAT > 2 times normal value)
- •Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
- •Proliferative diabetic retinopathy (anamnetic)
- •Atherosclerotic heart disease or heart failure (NYHA group III and IV)
- •Treatment with medicine which cannot be paused for 12 hours
- •Pregnancy and/or breast feeding
- •Fasting plasma glucose > 15 mM on the day of the experiment
排除标准
- 未提供
研究组 & 干预措施
Healthy volunteers
干预措施: glucose-dependent insulinotropic polypeptide (Drug)
Healthy volunteers
干预措施: Placebo (Drug)
Patients with Type 1 diabetes mellitus
干预措施: glucose-dependent insulinotropic polypeptide (Drug)
Patients with Type 1 diabetes mellitus
干预措施: Placebo (Drug)
Patients with type 2 diabetes mellitus
干预措施: glucose-dependent insulinotropic polypeptide (Drug)
Patients with type 2 diabetes mellitus
干预措施: Placebo (Drug)
结局指标
主要结局
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
时间窗: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
次要结局
- The difference between the amount of infused glucose and the insulin responses(will be measured at each visit)
研究者
Mikkel Christensen
MD, PhD
University Hospital, Gentofte, Copenhagen