An interventional study of Vildagliptin 50 mg and Placebo Oral Tablet in Healthy, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DPP-4 inhibitor, acute administration (50 mg.)
Drug: Vildagliptin 50 mg
Placebo treatment, acute administration
Drug: Placebo Oral Tablet
Acute administration of Vildagliptin, 50 mg.
Acute administration of placebo tablet
Change in intragastric pressure measured by high resolution manometry
Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility
Time frame: Until 2 hours after administration of study drug or placebo
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 2 hours after administration
Change in GLP-1 plasma concentrations
Time frame: 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
Food items were weighed before and after the buffet to measure food intake in grams.
Time frame: 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
Time frame: Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven