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

NCT06419686 | Recruiting Phase 1

• 1 other identifier: H-21066812
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Effect of iv Administration of GIP and Alanine

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of Glucagon

  Baseline

  Timepoint -30 to 90 minutes

• Plasma concentrations of Glucagon

  Baseline-corrected area under the curve (bsAUC)

  Timepoint -30 to 90 minutes

Secondary Outcomes (23)

• Serum concentration of Insulin

  Timepoint -30 to 90 minutes

• Serum concentration of Insulin

  Timepoint -30 to 90 minutes

• Serum concentration of C-peptid

  Timepoint -30 to 90 minutes

• Serum concentration of C-peptid

  Timepoint -30 to 90 minutes

• Plasma concentration of glucose

  Timepoint -30 to 90 minutes

Study Arms (4)

Saline

PLACEBO COMPARATOR

Intravenous administration of saline for 90 minutes.

Other: Placebo (saline)

GIP

EXPERIMENTAL

Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.

Drug: GIP

Alanine

EXPERIMENTAL

Intravenous administration of alanine for 90 minutes (28 umol/kg/min).

Drug: Alanine

GIP + Alanine

EXPERIMENTAL

Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes.

Drug: GIP + alanine

Interventions

Placebo (saline) OTHER

Intravenous saline during experimental days.

Saline

GIP DRUG

Intravenous GIP administration during experimental days.

GIP

Alanine DRUG

Intravenous alanine administration during experimental days.

Alanine

GIP + alanine DRUG

Intravenous administration of GIP and alanine during experimental days.

GIP + Alanine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian ethnicity
• Body mass index (BMI) 20-27 kg/m\^2
• Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
• Informed and written consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

Sodium Chloride; Alanine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Filip K Knop, MD, PhD

  Center for Clinical Metabolic Research, Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie V Warnøe, MD

CONTACT

+4527282263; julie.vilhelmine.warnoee.nielsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)