Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion

Phase 4

Completed

• Conditions: Healthy; Type 2 Diabetes
• Interventions: Drug: placebo; Drug: Sitagliptin

• Registration Number: NCT00885638
• Lead Sponsor: Lund University

Brief Summary

The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Detailed Description

Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Study Timeline

• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2009-08
• Primary Completion: 2011-05
• Study Completion: 2012-09
• Results First Submitted: 2012-09-21
• Results First Submitted QC: 2012-12-07
• Results First Posted: 2013-01-15
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-25
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy men
• Age 20-30 years
• BMI 20-30 kg/m2

Exclusion Criteria

• Any disease
• Any medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	A placebo tablet is given before ingestion of macronutrients
Sitagliptin	Sitagliptin	Sitagliptin is given before ingestion of macronutrients

Primary Outcome Measures

Name	Time	Method
Glucagon-like Peptide-1 Secretion After Meal Ingestion	300 min	Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion

Secondary Outcome Measures

Name	Time	Method
Insulin Secretion After Ingestion of Meal	300 min	Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion

Trial Locations

Locations (1)

Department of Clinical Sciences Lund, Lund University; 🇸🇪 Lund, Sweden