GA-18: The Role of Endogenous GIP in Glycosis Metabolism During Fasting
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Plasma glucagon concentrations
研究概览
简要总结
This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP[3-30]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion.
详细描述
This research project investigates the effects endogenous GIP has in the body of healthy, overweight people. Two trial days will be held. The participant will receive intravenous infusion of either GIP[3-30]NH2 (800 pmol/kg/min) or placebo (saline) in a randomized order. After 20 minutes, GIP[3-30]NH2 is expected to have maximum effect. On time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. When the participant is comfortably full, the infusion is turned off and the trial day ends. During the day, the participant assesses and notes on standardized VAS schedules current appetite, satiety, nausea, fatigue, malaise and thirst. Blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. In total, there will be drawn ten blood samples between intervals of 15 to 30 min. Three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).
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)
盲法说明
The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP[3-30]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-70 years
- •BMI > 30 kg/m2
- •Body fat percentage > 25 % for men og > 35 % for women
排除标准
- •Type 1 diabetes and/or type 2 diabetes diagnosis
- •Other chronic condition
- •Treatment with medications or supplements that cannot be paused for 12 hours
- •> 14 units of alcohol weekly or drug abuse
- •Circulating liver enzymes (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT)) ≥ 2 × normal value
- •Renal impairment (eGFR < 90 or creatinine level above the reference range)
- •Uncontrolled high resting blood pressure (above 140/90 mmHg)
- •Low blood percentage (hemoglobin < reference range (different for women and men))
- •Special diet or planned weight change within the trial period
- •Any disease/condition that investigators believe will interfere with study participation
结局指标
主要结局
Plasma glucagon concentrations
时间窗: Four hours
Measured in mmol/L. The primary endpoint is plasma glucagon concentrations during GIP\[3-30\]NH2 infusion compared to placebo.Area under the curve (AUC) for plasma glucagon (AUCglucagon) is quantified both as absolute and in baseline-subtracted values (bsAUCglucagon) and the effect of the GIP receptor antagonist will be calculated as a percentage reduction of bsAUC glucagon relative to bsAUC glucagon during the placebo infusion.
次要结局
- Plasma levels of insulin(Four hours)
- Activity in brown adipose tissue(10 minutes)
- Resting metabolic rate(15 minutes)
- Plasma levels of C-peptide(Four hours)
- Appetite(30 minutes)
- Blood pressure(Pre-intervention at time -30 and -20 min. During infusion at time 0 min, 30 min, 60 min, 90 min, 120 min, 160 min and 180 min.)
- Puls(Pre-intervention at time -30 and -20 minutes. During infusion at time 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 160 minutes, and 180 minutes)
研究者
Frederikke Koefoed-Hansen
Research Student
University Hospital, Gentofte, Copenhagen