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| Name | Class |
|---|---|
| Zealand Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIP infusion | Active Comparator | 5 hours of continuously GIP1-42 infusion |
|
| Saline | Placebo Comparator | 5 hours of continuously saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIP1-42 infusion | Biological | 5-hour GIP1-42 infusion (time point 0-300 minutes) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| food intake | food intake (kJ) eaten from an ad libitum meal of pasta bolognese | time point 300-330 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite | Appetite rated on visual analogue scales (0-10 mm) | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| satiety | Satiety rated on visual analogue scales (0-10 mm) |
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Inclusion criteria:
Exclusion criteria
male fænotype
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for diabetes research | Hellerup | DK-2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31949084 | Derived | Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline |
| Other |
5-hour infusion of saline (placebo) (time point 0-300 minutes) |
|
| time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| prospective food consumption | prospective food consumption rated on visual analogue scales (0-10 mm) | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| fullness | fullness rated on visual analogue scales (0-10 mm) | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| Thirst | Thirst rated on visual analogue scales (0-10 mm) | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| Nausea | Nausea rated on visual analogue scales (0-10 mm) | time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes |
| Energy expenditure | resting energy expenditure measured by indirect calorimetry (kcal/day) | measured at baseline and at time point 250 minutes |
| gastric emptying | acetaminophen test | ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| gallbladder emptying | gallbladder emptying evaluated by ultrasound | at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes |
| glucagon responses | blood samples | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| Insulin responses | blood samples | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| C-peptide responses | blood samples | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| gut hormone responses | Blood samples | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| bone turnover markers | Blood samples | at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |