NCT03526289已完成不适用
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年11月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- food intake
研究概览
简要总结
The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.
详细描述
The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Caucasian men
- •Age between 18 and 70 years
- •Body mass index (BMI) between 25 and 40 kg/m2
- •Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
- •In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
- •Informed consent
排除标准
- •Anaemia (haemoglobin outside normal range)
- •Any current or prior gastrointestinal disease that may interfere with the endpoint variables
- •Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
- •Nephropathy (serum creatinine above normal range and/or albuminuria).
- •Anorexia, bulimia or binge eating disorder
- •Allergy or intolerance to ingredients included in the standardised meals
- •Tobacco smoking
- •Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
- •Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
- •Any physical or psychological condition that the investigator feels would interfere with trial participation
研究组 & 干预措施
GIP infusion
Active Comparator
5 hours of continuously GIP1-42 infusion
干预措施: GIP1-42 infusion (Biological)
Saline
Placebo Comparator
5 hours of continuously saline infusion
干预措施: Saline (Other)
结局指标
主要结局
food intake
时间窗: time point 300-330 minutes
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
次要结局
- Energy expenditure(measured at baseline and at time point 250 minutes)
- prospective food consumption(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- Nausea(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- Insulin responses(at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
- Appetite(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- Thirst(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- gastric emptying(ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
- glucagon responses(at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
- satiety(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- fullness(time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes)
- gallbladder emptying(at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes)
- C-peptide responses(at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
- gut hormone responses(at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
- bone turnover markers(at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes)
研究者
Natasha Chidekel Bergmann
Medical doctor
University Hospital, Gentofte, Copenhagen
研究点 (2)
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