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GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake (GASOLIN II)

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ClinicalTrials.gov Identifier: NCT03526289
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Zealand Pharma
Information provided by (Responsible Party):
Natasha Chidekel Bergmann, University Hospital, Gentofte, Copenhagen

Study Description
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Brief Summary:
The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Overweight and Obesity Biological: GIP1-42 infusion Other: Saline Not Applicable

Detailed Description:
The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GIP infusion
5 hours of continuously GIP1-42 infusion
 Biological: GIP1-42 infusion
5-hour GIP1-42 infusion (time point 0-300 minutes)
Placebo Comparator: Saline
5 hours of continuously saline infusion
 Other: Saline
5-hour infusion of saline (placebo) (time point 0-300 minutes)


Outcome Measures
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Primary Outcome Measures :
  1. food intake [ Time Frame: time point 300-330 minutes ]
    food intake (kJ) eaten from an ad libitum meal of pasta bolognese


Secondary Outcome Measures :
  1. Appetite [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    Appetite rated on visual analogue scales (0-10 mm)

  2. satiety [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    Satiety rated on visual analogue scales (0-10 mm)

  3. prospective food consumption [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    prospective food consumption rated on visual analogue scales (0-10 mm)

  4. fullness [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    fullness rated on visual analogue scales (0-10 mm)

  5. Thirst [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    Thirst rated on visual analogue scales (0-10 mm)

  6. Nausea [ Time Frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes ]
    Nausea rated on visual analogue scales (0-10 mm)

  7. Energy expenditure [ Time Frame: measured at baseline and at time point 250 minutes ]
    resting energy expenditure measured by indirect calorimetry (kcal/day)

  8. gastric emptying [ Time Frame: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    acetaminophen test

  9. gallbladder emptying [ Time Frame: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes ]
    gallbladder emptying evaluated by ultrasound

  10. glucagon responses [ Time Frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    blood samples

  11. Insulin responses [ Time Frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    blood samples

  12. C-peptide responses [ Time Frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    blood samples

  13. gut hormone responses [ Time Frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    Blood samples

  14. bone turnover markers [ Time Frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes ]
    Blood samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male fænotype
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Caucasian men
  • Age between 18 and 70 years
  • Body mass index (BMI) between 25 and 40 kg/m2
  • Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
  • In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
  • Informed consent

Exclusion criteria

  • Anaemia (haemoglobin outside normal range)
  • Any current or prior gastrointestinal disease that may interfere with the endpoint variables
  • Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
  • Nephropathy (serum creatinine above normal range and/or albuminuria).
  • Anorexia, bulimia or binge eating disorder
  • Allergy or intolerance to ingredients included in the standardised meals
  • Tobacco smoking
  • Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
  • Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
  • Any physical or psychological condition that the investigator feels would interfere with trial participation
Contacts and Locations
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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): NCT03526289


Locations
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Denmark
Center for diabetes research
Hellerup, Denmark, DK-2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Zealand Pharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Natasha Chidekel Bergmann, Medical doctor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03526289    
Other Study ID Numbers: H-16031728
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Body Weight