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Completed

NCT Number: NCT03526289

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIP1-42 infusion

Biological

5-hour GIP1-42 infusion (time point 0-300 minutes)

Saline

Other

5-hour infusion of saline (placebo) (time point 0-300 minutes)

Primary outcomes

  1. food intake

    Time frame: time point 300-330 minutes

    food intake (kJ) eaten from an ad libitum meal of pasta bolognese

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Zealand Pharma

Registry information

Acronym: GASOLIN II

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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