GASOLIN II: GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- food intake [time point 300-330 minutes]
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Secondary Outcome Measures
- Appetite [time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes]
Appetite rated on visual analogue scales (0-10 mm)
- 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)
- gastric emptying [ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes]
acetaminophen test
- 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
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for diabetes research | Hellerup | Denmark | DK-2900 |
Sponsors and Collaborators
- University Hospital, Gentofte, Copenhagen
- Zealand Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-16031728