NCT03556098已完成不适用
Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- plasma glucose concentration
研究概览
简要总结
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.
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 peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant..
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
- •Body mass index between 20-27 kg/m^2
- •T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c<69 mmol/l (<8,5%)
- •T1D duration between 2-20 years
- •Stimulated C-peptide ≤ 100 pmol/mL)
- •Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
- •Informed consent
排除标准
- •Anemia (hemoglobin below normal range)
- •Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
- •Nephropathy (serum creatinine above normal range and/or albuminuria)
- •Allergy or intolerance to ingredients included in the standardized meals
- •Prior myocardial infarction or other cardiac events
- •Any physical or psychological condition that the investigator fells would interfere with trial participation
- •Treatment with any glucose-lowering drugs beside insulin
研究组 & 干预措施
GIP
Active Comparator
Infusion of Glucose-dependent insulinotropic peptide
干预措施: glucose-dependent insulinotropic peptide (Drug)
GIP[3-30]
Active Comparator
Infusion of GIP[3-30]
干预措施: Glucose-Dependent Insulin-Releasing Hormone[3-30] (Drug)
Saline
Placebo Comparator
Infusion of saline
干预措施: Saline Solution (Drug)
结局指标
主要结局
plasma glucose concentration
时间窗: At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days
plasma glucose excursions and plasma glucose nadir
次要结局
- Fat Hormonse-sensitive lipase (HSL)(At time 240 minute on study days)
- Glucose regulatory hormones(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- Incretin hormones(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- Free fatty acids (FFA)(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- Blood analysis of paracetamol as an assessment of gastric emptying(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- Fat mRNA(At time 240 minute on study days)
- Fat Lipoprotein lipase (LPL)(At time 240 minute on study days)
- Fat Perilipin 4(At time 240 minute on study days)
- Fat Fatty acid binding protein 4 (FABP4)(At time 240 minute on study days)
- Pulse(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- GIP[3-30](At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
- Fat Vascular endothelial growth factor 4 (VEGF-A)(At time 240 minute on study days)
- Fat GIP receptor (GIPR)(At time 240 minute on study days)
- Blood pressure(At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days)
研究者
Bjørn Hoe
Medical Doctor, PhD student, Prinicipal Investigator
Steno Diabetes Center Copenhagen
研究点 (1)
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