Vildagliptin on Gastric Accommodation

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Healthy

Treatments: Drug: Vildagliptin 50 mg; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03500900

Vildagliptin

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Description:

DPP-4 inhibitor, acute administration (50 mg.)

Treatment:

Drug: Vildagliptin 50 mg

Placebo

Placebo Comparator group

Description:

Placebo treatment, acute administration

Treatment:

Drug: Placebo Oral Tablet