Effect of Glucagon-like Peptide 2 on Gallbladder Motility After a Meal in Young, Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT03682172|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Effect of Glucagon-like Peptide 2 on Gallbladder Motility||Drug: GLP-2 (1pmol/kg/min) Drug: GLP-2 (10pmol/kg/min) Drug: Placebo||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||It is a blinded, randomized, placebo controlled study where 15 participants receive three different 4 hour intravenous infusions of either saline (placebo), low GLP-2 (at a rate of 1pmol/kg/min) or high GLP-2 (at a rate of 10pmol/kg/min) on three different study days.|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Glucagon-like Peptide 2 on Postprandial Gallbladder Motility in Healthy Subjects|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||August 30, 2018|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: GLP-2 (10pmol/kg/min)
A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10pmol/kg/min
Drug: GLP-2 (10pmol/kg/min)
Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10 pmol/kg/min
Experimental: GLP-2 (1pmol/kg/min)
A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min
Drug: GLP-2 (1pmol/kg/min)
Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min
A single four hour intravenous infusion with saline water (placebo)
Four hour intravenous infusion with saline water
- Gallbladder ejection fraction (EF%) [ Time Frame: 0-210 minutes ]Incremental Area Under the Curve (iAUC) for gallbladder ejection fraction (EF%) at time 0-210 minutes.
- Glucagon [ Time Frame: -30-200 minutes ]Incremental Area Under the Curve (iAUC) (-30;200min) of glucagon plasma concentration.
- Gastric emptying [ Time Frame: 0-200 minutes ]Gastric emptying will be determined by the by paracetamol curve following ingestion of the meal (mixed with 1500 mg paracetamol).
- Time to maximum gallbladder EF% [ Time Frame: 0-210 minutes ]Time to reach maximum gallbladder ejection fraction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682172
|Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen|
|Hellerup, Region Hovedstaden, Denmark, 2900|
|Principal Investigator:||Filip K Knop, MD, phd||Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen|