Overweight and Obesity, Type 2 Diabetes Mellitus
Conditions
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.
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.
Interventions
BIOLOGICALGIP1-42 infusion
5-hour GIP1-42 infusion (time point 0-300 minutes)
OTHERSaline
5-hour infusion of saline (placebo) (time point 0-300 minutes)
Sponsors
Zealand Pharma
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| food intake | time point 300-330 minutes | food intake (kJ) eaten from an ad libitum meal of pasta bolognese |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| satiety | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes | Satiety rated on visual analogue scales (0-10 mm) |
| prospective food consumption | 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) |
| fullness | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes | fullness rated on visual analogue scales (0-10 mm) |
| Thirst | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes | Thirst rated on visual analogue scales (0-10 mm) |
| Nausea | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes | Nausea rated on visual analogue scales (0-10 mm) |
| Energy expenditure | measured at baseline and at time point 250 minutes | resting energy expenditure measured by indirect calorimetry (kcal/day) |
| Appetite | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes | Appetite rated on visual analogue scales (0-10 mm) |
| gallbladder emptying | at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes | gallbladder emptying evaluated by ultrasound |
| glucagon responses | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | blood samples |
| Insulin responses | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | blood samples |
| C-peptide responses | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | blood samples |
| gut hormone responses | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | Blood samples |
| bone turnover markers | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | Blood samples |
| gastric emptying | ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes | acetaminophen test |
Countries
Denmark
Outcome results
None listed