NCT03734718已完成不适用
The Role of Glucose-dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis of Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood glucose
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 the daily life of participants with type 1 Diabetes
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
- Triple (Participant, Care Provider, 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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 20 and 27 kg/m2
- •T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- •Treatment with a stable insulin regimen ≥3 months
- •T1D duration between 2 and 15years
- •C-peptide negative (C-peptide ≤ 16 ng/ml)
- •Informed consent
排除标准
- •Anemia (hemoglobin outside normal range)
- •Known liver disease and/or ALAT and/or ASAT > 2 times normal values
- •Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
- •Prior Cardiovascular events and/or abnormal heart rate/blood pressure
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
- •Any physical or psychological condition that the investigator feels would interfere with trial participation
研究组 & 干预措施
Glucose-Dependent Insulinotropic Polypeptide
Active Comparator
6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide
干预措施: GIP (Drug)
Placebo
Placebo Comparator
Saline
干预措施: GIP (Drug)
结局指标
主要结局
Blood glucose
时间窗: an average of 6 days
Time spent in hypoglycemia, near-normoglycemia and hyperglycemia
次要结局
- Fat Protein content(Evaluated at experimental day 0,1 and 6 of each intervention)
- Number of symptomatic hypoglycemic events(An average of 1 week)
- Incretin hormones(Evaluated at experimental day 0,1 and 6 of each intervention)
- Free fatty acids (FFA)(Evaluated at experimental day 0,1 and 6 of each intervention)
- Fat mRNA(At day 6, and 10 of the study)
- Pulse(The first 24 hours of intervention and at experimental day 6)
- Glucose regulatory hormones(Evaluated at experimental day 0,1 and 6 of each intervention)
- Blood pressure(The first 24 hours of intervention and at experimental day 6)
研究者
研究点 (1)
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