Vildagliptin on Gastric Accommodation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500900
• Other study ID #: Vildagliptin
• Status: Completed
• Phase: N/A
• First received: January 18, 2018
• Last updated: April 16, 2018
• Start date: March 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: January 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Vildagliptin 50 mg
Acute administration of Vildagliptin, 50 mg.
• Placebo Oral Tablet
Acute administration of placebo tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.