Effect of Glucagon-like Peptide 2 on Gallbladder Motility After a Meal in Young, Healthy Male Subjects

• Status: Active, not recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study will investigate the effect of the incretin hormone glucagon-like peptide 2 (GLP-2) on postprandial gallbladder motility in young, healthy, male subjects.

The study is double-blinded, randomized and placebo controlled. 15 subjects will be included. On three separate study days (A, B, C) the subjects will receive an four hour intravenous infusion with either saline (placebo), GLP-2 at a rate of 1 pmol/kg/min or GLP-2 at a rate of 10 pmol/kg/min 30 minutes after the infusion start the subject will receive a liquid meal which will stimulate gallbladder contraction.

The gallbladder volume will be determined by frequent ultrasonic scans, and blood samples will be drawn on fixed times through out the study day.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Caucasian ethnicity

• Male

• Age: 18-35 years

• BMI: 18,5-24,9

• Fasting plasma glucose ≤ 6 mmol/l

• Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol

• Normal haemoglobin (8,3-10,5 mmol/l)

• Informed and written consent

Exclusion Criteria:

• First-degree relatives with type 1 or type 2 diabetes

• Nephropathy (se-creatinin > 130 μM and/or albuminuria)

• Liver disease (alanintransaminase (ALAT) or aspartattransaminase (ASAT) > 2 × upper normal limit)

• Active or recent malignant disease

• Treatment with medicine that cannot be paused for 1 week

• Any treatment or condition requiring acute or sub-acute medical or surgical intervention

• Any condition considered incompatible with participation by the investigators