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Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4 inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.
The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will include ten volunteers.
Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be intragastrically infused and intragastric pressure (IGP) will be measured for one hour.
Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal). Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for 30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | DPP-4 inhibitor, acute administration (50 mg.) |
|
| Placebo | Placebo Comparator | Placebo treatment, acute administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin 50 mg | Drug | Acute administration of Vildagliptin, 50 mg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intragastric pressure measured by high resolution manometry | Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility | Until 2 hours after administration of study drug or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm | assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 2 hours after administration | |
| Change in GLP-1 plasma concentrations | Blood samples to assess active GLP-1 plasma levels were collected immediately before medication or placebo administration, 55 minutes, 75 minutes and 120 minutes after medication or placebo administration. |
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Inclusion Criteria:
- Aged between 18 to 65 years old
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo Oral Tablet |
| Drug |
Acute administration of placebo tablet |
|
| Ad libitum food intake in grams | Food items were weighed before and after the buffet to measure food intake in grams. | Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation. |
| Ad libitum food intake in kcal | Caloric intake of each of the consumed food items was calculated for each subject in a unit of kcal | Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation. |
| D006571 |
| Heterocyclic Compounds |