Vildagliptin on Gastric Accommodation

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Vildagliptin 50 mg; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vildagliptin; DPP-4 inhibitor, acute administration (50 mg.)	Drug: Vildagliptin 50 mg; Acute administration of Vildagliptin, 50 mg.
PLACEBO_COMPARATOR: Placebo; Placebo treatment, acute administration	Drug: Placebo Oral Tablet; Acute administration of placebo tablet

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: gastrointestinal hormones; food intake; gastric accommodation
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Vildagliptin
• Other Study ID Numbers: Vildagliptin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No