GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake (GASOLIN)

December 4, 2018 updated by: Natasha Chidekel Bergmann, University Hospital, Gentofte, Copenhagen
We aim to delineate the effects of separate and combined infusion of GIP and GLP-1 on food intake, appetite, bone health and fat metabolism in overweight/obese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The gut-derived incretin glucagon-like peptide-1 (GLP-1) is a potent regulator of gastric emptying, appetite and food intake in humans whereas its sister incretin hormone, glucose-dependent insulinotropic polypeptide (GIP), does not seem to have independent effects on these variables in humans. Interestingly, recent data from rodents have shown that concomitant activation of the GIP and the GLP-1 receptor may potentiate the satiety-promoting and body weight-reducing effects of GLP-1. Also, evidence suggests that GIP may be an important mediator of bone remodelling and lipid deposition. The effect of simultaneous activation of the GIP and GLP-1 receptors on appetite, food intake, fat metabolism and bone health has not been thoroughly examined in humans. The aim of this study is to delineate the effects of GIP/GLP-1 receptor co-activation on food intake, mechanisms regulating food intake, fat and bone metabolism in obese subjects.

Material and methods:

The investigators plan to include 18 obese/overweight men without diabetes. The primary endpoint of the study is food intake during continuous intravenous infusions of saline (placebo), GIP, GLP-1 and GIP+GLP-1, respectively. Secondary endpoints includes resting energy expenditure (measured by indirect calorimetry), appetite, satiety and hunger assessments (measured by visual analogue scales), plasma insulin, C-peptide and glucagon secretion, plasma triglycerides, cholesterols, and free fatty acid responses and changes in plasma bone turnover markers.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Diabetesresearch, Gentofte hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasian men
  • Age between 25 and 70 years
  • Body mass index (BMI) between 25 and 40 kg/m2

Exclusion Criteria:

  • Diabetes or prediabetes (defined as glycated haemoglobin (HbA1c) ≥ 43 mmol/mol)
  • Anaemia (defined as haemoglobin < 8.3 mmol/l)
  • Any gastrointestinal disease that may interfere with the endpoint variables
  • Anorexia, bulimia or binge eating disorder
  • Allergy or intolerance to ingredients included in the standardised meals
  • Tobacco smoking
  • Any regular drug treatment that cannot be discontinued for minimum 18 hours
  • Any physical or psychological condition that the investigator feels would interfere with trial participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IIGI+GIP
4 hour i.v. infusion of glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemic conditions
Other: IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
Other: IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
Other: IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
Other: OGTT
50 g oral glucose tolerance test
Other: IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Active Comparator: IIGI+GLP-1
4 hour i.v. infusion of glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemic conditions
Other: IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
Other: IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
Other: IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
Other: OGTT
50 g oral glucose tolerance test
Other: IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Placebo Comparator: IIGI+NaCl (placebo)
4 hour i.v. NaCl (placebo) during isoglycemic conditions
Other: IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
Other: IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
Other: IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
Other: OGTT
50 g oral glucose tolerance test
Other: IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Active Comparator: IIGI+GIP+GLP-1
4 hour co-infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1
Other: IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
Other: IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
Other: IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
Other: OGTT
50 g oral glucose tolerance test
Other: IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Other: 50 g OGTT
50 g oral glucose tolerance test (OGTT)
Other: IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
Other: IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
Other: IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
Other: OGTT
50 g oral glucose tolerance test
Other: IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
food intake
Time Frame: 250-280 min
How much does the participant eat of from the ad libitum meal, measured in gram
250-280 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hunger
Time Frame: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
feeling of hunger measured on a visual analogue scale
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
satiety
Time Frame: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
feeling of satiety measured on a visual analogue scale
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
Fullness
Time Frame: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
feeling of fullness measured on a visual analogue scale
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
Prospective food consumption
Time Frame: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
Prospective food consumption measured on a visual analogue scale
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
resting energy expenditure (REE)
Time Frame: -15 to 0 min. and 210 to 225 min.
changes in REE measured by a ventilated hood 15 minutes at baseline and 15 minutes at time point 210 min.
-15 to 0 min. and 210 to 225 min.
Insulin
Time Frame: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
changes in insulin measured in serum
-30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
C-peptide level
Time Frame: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
changes in C-peptide level measured in serum
-30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
glucagon levels
Time Frame: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
changes in glucagon levels measured in plasma
-30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min
Cholesterol and FFA
Time Frame: -30, 0, 30, 60, 90, 120, 180, 240 min
changes in cholesterol (TAG, Total cholesterol and free fatty acid measured in plasma)
-30, 0, 30, 60, 90, 120, 180, 240 min
C-terminal cross-linked telopeptide of bone collagen (CTX)
Time Frame: -30, 0, 30, 60, 90, 120, 180, 240 min
changes in level of CTX measured in plasma
-30, 0, 30, 60, 90, 120, 180, 240 min
procollagen type 1 N-terminal propeptide (P1NP)
Time Frame: -30, 0, 30, 60, 90, 120, 180, 240 min
changes in level of P1NP measured in plasma
-30, 0, 30, 60, 90, 120, 180, 240 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Natasha C Bergmann, MD, Center for Diabetesresearch, Gentofte Hospital, University of Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

June 20, 2016

Study Completion (Actual)

June 20, 2016

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15008790 (GASOLIN)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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