The Effect of Exogenous Glucagon-like Peptide 2 on Cholecystokinin-induced Gallbladder Emptying

NCT04651868 | Completed

• 1 other identifier: H-20039104
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized, double-blinded, placebo-controlled, cross-over study, which will investigate the acute effects of the gut-derived hormone glucagon-like peptide 2 (GLP-2) on cholecystokinin (CCK)-induced gallbladder emptying. Furthermore, the investigators will investigate different hormonal responses and appetite during the study days. The investigators hypothesize that GLP-2 will overrule the potent gallbladder relaxing effect of CCK. We will include 15 healthy male participants, and each of the participants will participate in four study days. GLP-2 and CCK will be given intravenously, and will be placebo-controlled. Gallbladder volume will be determined by frequent ultrasonography scans. Appetite will be assessed by Visual Analog Scales through out the study day and an ad libitum meal at the end of the study day. Blood samples will be drawn at regular intervals to asses different hormonal responses.

Conditions

Gallbladder

Keywords

Glucagon-Like Peptide 2; Gallbladder; Gallbladder Motility

Outcome Measures

Primary Outcomes (1)

• Gallbladder volume

  Baseline subtracted area under the curve for gallbladder volume

  0 to 240 minutes

Secondary Outcomes (13)

• Maximum gallbladder ejection fraction

  0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 195, 210 and 240 minutes

• GLP-2

  -15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes

• CCK

  -15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes

• Bile Acids

  -15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes

• Cholesterols

  -15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes

Study Arms (4)

CCK + GLP-2

EXPERIMENTAL

A 180 mins intravenous infusion with cholecystokinin (0.4 pmol × kg\^-1 × min\^-1) and a 210 mins intravenous infusion with GLP-2 (10 pmol × kg\^-1 × min\^-1)

Other: GLP-2; Other: CCK

CCK + placebo

EXPERIMENTAL

A 180 mins intravenous infusion with cholecystokinin (0.4 pmol × kg\^-1 × min\^-1) and a 210 mins intravenous infusion with isotonic NaCl

Other: Placebo; Other: CCK

Placebo + GLP-2

EXPERIMENTAL

A 180 mins intravenous infusion with isotonic NaCl and a 210 mins intravenous infusion with GLP-2 (10 pmol × kg\^-1 × min\^-1)

Other: GLP-2; Other: Placebo

Placebo + placebo

EXPERIMENTAL

A 180 mins intravenous infusion with isotonic NaCl and a 210 mins intravenous infusion with isotonic NaCl

Other: Placebo

Interventions

GLP-2 OTHER

A 210 mins intravenous infusion with GLP-2 (10 pmol × kg\^-1 × min\^-1)

CCK + GLP-2; Placebo + GLP-2

Placebo OTHER

A 210 mins intravenous infusion with isotonic NaCl

CCK + placebo; Placebo + placebo

CCK OTHER

A 180 mins intravenous infusion with cholecystokinin (0.4 pmol × kg\^-1 × min\^-1)

CCK + GLP-2; CCK + placebo

Eligibility Criteria

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

You may qualify if:

• Caucasian ethnicity
• Male gender
• Age 18-65 years
• Body mass index (BMI) 18.5-24.9 kg/m2
• Fasting plasma glucose ≤6 mmol/l and glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
• Normal hemoglobin (males 8.3-10.5 mmol/l)
• Informed and written consent

You may not qualify if:

• Nephropathy (eGFR \< 90 ml/min/1.73m2 and/or albuminuria)
• Known liver disease and/or alanine aminotransaminase (ALAT) and/or aspartate transaminase (ASAT) \> 2 × upper normal reference limit
• Active or recent (within 5 years) malignant disease
• Any history of colon cancer
• Treatment with medicine that cannot be paused for 1 week
• Active tobacco smoking
• Any condition considered incompatible with participation by the investigators

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator

Study Sites (1)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

• Lange AH, Hansen NL, Pedersen MG, Nerild HH, Rehfeld JF, Hartmann B, Holst JJ, Ellegaard AM, Knop FK. Exogenous Glucagon-like Peptide 2 Counteracts Exogenous Cholecystokinin-induced Gallbladder Contraction in Healthy Men. J Clin Endocrinol Metab. 2024 Dec 18;110(1):123-129. doi: 10.1210/clinem/dgae421.

  PMID: 38888179 DERIVED

Study Officials

• Nina L Hansen, MD

  Center for Clinical Metabolic Research, Genofte University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Day A, B, C and D will be conducted in a randomized and double-blinded order (blinded for the participant and the investigator). The infusion order will be unblinded after the last patient last visit.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: December 10, 2020
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DK (1)