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临床试验/NCT06881472
NCT06881472进行中(未招募)不适用

The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Subjects With and Without Type 1 Diabetes

Asger Lund, MD1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
10
试验地点
1
主要终点
bsAUC of glucagon concentration

研究概览

简要总结

The hormone glucose-dependent insulinotropic polypeptide (GIP) is naturally produced in the intestine during a meal and stimulates insulin secretion from the pancreas. Insulin ensures that nutrients from the meal are transported from the blood into the cells, allowing the body to use it as energy. If blood sugar levels drop too much, the body naturally releases another hormone: glucagon. Glucagon is responsible for the breakdown of nutrients inside the cells, thus causing blood sugar levels to rise again. This occurs, for example, when a person is fasting or in an energy deficit. Unfortunately, glucagon is not released in people with type 1 diabetes when blood sugar levels are low. However, it is known that GIP contributes to the secretion of glucagon during low blood sugar levels in both healthy individuals and those with type 1 diabetes.

Protein intake through the diet is broken down in the body into amino acids. It is known that the ingestion of protein and thus amino acids leads to an increase in glucagon in both healthy individuals and those with type 1 diabetes. This causes the amino acids to be converted into sugar, but also allows potentially harmful waste products from the breakdown to be converted into harmless components. The relationship between GIP and amino acids, as well as their joint effect on glucagon, is still unknown, but studies in mice have shown that if GIP and amino acids are given simultaneously, glucagon secretion will be even higher than if they were administered separately. The purpose of this study is to gain a better understanding of how the three (GIP, amino acids, and glucagon) are interconnected and affect each other and to see if the experiments conducted in mice yield the same results in healthy individuals and those with type 1 diabetes. Moreover, the secretion of glucagon, and thus the increase in blood sugar, might protect individuals with type 1 diabetes from experiencing low blood sugar. This knowledge could potentially be used for new treatment approaches in diabetes in the future.

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, Investigator, Outcomes Assessor)

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 ethnicity
  • •Age between 18 and 70 years
  • •T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
  • •Body mass index between 20-27 kg/m2
  • •T1D duration of 2-20 years
  • •C-peptide negative (arginin-stimulated C-peptide ≤ 100 pmol/l)
  • •Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
  • •Informed and written consent

排除标准

  • •Anaemia (haemoglobin below normal range)
  • •Late microvascular complications except mild nonproliferative retinopathy
  • •Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
  • •Treatment with any glucose-lowering drugs beside insulin
  • •Active or recent (within 5 years) malignant disease
  • •Active tobacco smoking / use
  • •Any condition considered incompatible with participation by the investigators

研究组 & 干预措施

GIP

Active Comparator

干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)

GIP

Active Comparator

干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)

Alanine

Active Comparator

干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)

GIP + Alanine

Active Comparator

干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)

Placebo

Placebo Comparator

干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)

GIP + Alanine

Active Comparator

干预措施: alanine (Drug)

Alanine

Active Comparator

干预措施: alanine (Drug)

结局指标

主要结局

bsAUC of glucagon concentration

时间窗: From 0-150 minutes

Baseline Area under the curve of Glucagon concentration

次要结局

  • bsAUC Glucagon 30-90(from 30-90 minutes)
  • bsAUC glucagon 90-150 min(from 90-150 minutes)

研究者

发起方
Asger Lund, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asger Lund, MD

Associate professor, MD, Ph.D.

University Hospital, Gentofte, Copenhagen

研究点 (1)

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