Effects of GIP and Alanine on Glucagon Levels in Healthy Men
The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
This study is testing if giving healthy men a hormone called GIP and an amino acid called alanine can change their glucagon levels when their blood sugar is normal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University Hospital, Gentofte, Copenhagen Academic / other |
| Locations | 1 site (Hellerup, Capital Region) |
| Trial ID | NCT06419686 on ClinicalTrials.gov |
What this trial studies
This study investigates the glucagonotropic effects of intravenous administration of glucose-dependent insulinotropic polypeptide (GIP) and alanine in healthy male participants. It is designed as a randomized, double-blinded, placebo-controlled, crossover study involving 10 participants who will undergo four different treatment days. Each treatment day will include a continuous 90-minute infusion of either placebo, GIP, alanine, or a combination of GIP and alanine. The primary goal is to determine the effects of these substances on glucagon levels during normal blood sugar conditions.
Who should consider this trial
Good fit: Ideal candidates are healthy Caucasian males with a BMI between 20-27 kg/m² and normal blood sugar levels.
Not a fit: Patients with liver disease, recent malignancies, or those on glucose-lowering medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how GIP and alanine influence glucagon levels, potentially leading to new treatments for metabolic disorders.
How similar studies have performed: While this approach is novel, similar studies investigating the effects of gut hormones on metabolism have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caucasian ethnicity * Body mass index (BMI) 20-27 kg/m\^2 * Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol * Informed and written consent Exclusion Criteria: * 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.
Where this trial is running
Hellerup, Capital Region
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Filip K Knop, MD, PhD — Center for Clinical Metabolic Research, Gentofte Hospital
- Study coordinator: Julie V Warnøe, MD
- Email: julie.vilhelmine.warnoee.nielsen@regionh.dk
- Phone: +4527282263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.