Vildagliptin on Gastric Accommodation

NCT03500900 | Completed

• 1 other identifier: Vildagliptin
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

gastric accommodation; food intake; gastrointestinal hormones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation.

Study Arms (2)

Vildagliptin

EXPERIMENTAL

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

Drug: Vildagliptin 50 mg

Placebo

PLACEBO COMPARATOR

Placebo treatment, acute administration

Drug: Placebo Oral Tablet

Interventions

Vildagliptin 50 mg DRUG

Acute administration of Vildagliptin, 50 mg.

Vildagliptin

Placebo Oral Tablet DRUG

Acute administration of placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Aged between 18 to 65 years old

You may not qualify if:

• presence of symptoms or a history of gastrointestinal diseases
• diabetes
• drug allergies
• psychological disorders
• major gastrointestinal surgery

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Interventions

Vildagliptin

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: April 18, 2018
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share