Actively Recruiting

Phase 1
Age: 18Years - 70Years
MALE
Healthy Volunteers
NCT06419686

The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

Led by University Hospital, Gentofte, Copenhagen · Updated on 2024-05-17

10

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine. The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.

CONDITIONS

Official Title

The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

Who Can Participate

Age: 18Years - 70Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caucasian ethnicity
  • Body mass index (BMI) 20-27 kg/m^2
  • Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
  • Informed and written consent
Not Eligible

You will not qualify if you...

  • 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
  • Active or recent (within 5 years) malignant disease
  • Active tobacco smoking/use
  • Any condition considered incompatible with participation by the investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, Denmark, 2900

Actively Recruiting

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Research Team

J

Julie V Warnøe, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals | DecenTrialz