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Trial record 92 of 750 for:    Area Under Curve AND meal

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682172
Recruitment Status : Active, not recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
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

Experimental: Placebo
A single four hour intravenous infusion with saline water (placebo)
Drug: Placebo
Four hour intravenous infusion with saline water




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Glucagon [ Time Frame: -30-200 minutes ]
    Incremental Area Under the Curve (iAUC) (-30;200min) of glucagon plasma concentration.

  2. 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).

  3. Time to maximum gallbladder EF% [ Time Frame: 0-210 minutes ]
    Time to reach maximum gallbladder ejection fraction.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Denmark
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, Region Hovedstaden, Denmark, 2900
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Filip K Knop, MD, phd Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03682172     History of Changes
Other Study ID Numbers: H-17037571
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steno Diabetes Center Copenhagen:
Gallbladder Motility
Gallbladder Emptying
Glucagon-Like Peptide 2
Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins