Healthy
Conditions
Keywords
gastric accommodation, food intake, gastrointestinal hormones
Brief summary
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.
Interventions
Acute administration of Vildagliptin, 50 mg.
DRUGPlacebo Oral Tablet
Acute administration of placebo tablet
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- Aged between 18 to 65 years old
Exclusion criteria
* presence of symptoms or a history of gastrointestinal diseases * diabetes * drug allergies * psychological disorders * major gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intragastric pressure measured by high resolution manometry | Until 2 hours after administration of study drug or placebo | Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| Ad libitum 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. | Food items were weighed before and after the buffet to measure food intake in grams. |
| Ad libitum food intake in 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. | Caloric intake of each of the consumed food items was calculated for each subject in a unit of kcal |
Outcome results
None listed