Vildagliptin on Gastric Accommodation

Study Overview
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Brief Summary
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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.

Official Title
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Effect of the DPP-4 Inhibitor, Vildagliptin, on Gastric Accommodation and Food Intake in Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: Vildagliptin 50 mg
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>DPP-4 inhibitor, acute administration (50 mg.) | Drug: Vildagliptin 50 mg<br>* Acute administration of Vildagliptin, 50 mg.<br>|
| Placebo Comparator: Placebo<br>Placebo treatment, acute administration | Drug: Placebo Oral Tablet<br>* Acute administration of placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric accommodation, food intake, gastrointestinal hormones