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Completed

NCT Number: NCT06881472

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Glucose-dependent Insulinotropic Polypeptide (GIP)

Drug

GIP

alanine

Drug

Alanine

Saline (NaCl 0,9 %) (placebo)

Drug

Placebo

Primary outcomes

  1. bsAUC of glucagon concentration

    Time frame: From 0-150 minutes

    Baseline Area under the curve of Glucagon concentration

Secondary outcomes

  1. bsAUC Glucagon 30-90

    Time frame: from 30-90 minutes

    Baseline corrected area under the curve of time spend in hyoglycaemia

  2. bsAUC glucagon 90-150 min

    Time frame: from 90-150 minutes

    bs Glucagon in the recovery period

Sponsors and collaborators

Lead sponsor

Asger Lund, MD

Other

Registry information

Acronym: GIPALANIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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