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Completed

NCT Number: NCT03500900

Vildagliptin on Gastric Accommodation

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin 50 mg

Drug

Acute administration of Vildagliptin, 50 mg.

Placebo oral tablet

Drug

Acute administration of placebo tablet

Primary outcomes

  1. Change in intragastric pressure measured by high resolution manometry

    Time frame: Until 2 hours after administration of study drug or placebo

    Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility

Secondary outcomes

  1. 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

  2. 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.

  3. Ad libitum 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.

    Food items were weighed before and after the buffet to measure food intake in grams.

  4. Ad libitum food intake in 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.

    Caloric intake of each of the consumed food items was calculated for each subject in a unit of kcal

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2018
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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