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

Healthy Clinical Trial

Official title:

Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885638
• Other study ID #: Lund University Diabetes 001
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2009
• Last updated: December 25, 2013
• Start date: August 2009
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy men

• Age 20-30 years

• BMI 20-30 kg/m2

Exclusion Criteria:

• Any disease

• Any medication

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
100 mg sitagliptin before ingestion of macronutrient
• placebo
A placebo tablet is given before ingestion of macronutrients

Locations

Country	Name	City	State
Sweden	Department of Clinical Sciences Lund, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Carr RD, Larsen MO, Winzell MS, Jelic K, Lindgren O, Deacon CF, Ahrén B. Incretin and islet hormonal responses to fat and protein ingestion in healthy men. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E779-84. doi: 10.1152/ajpendo.90233.2008. Epub 2008 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon-like Peptide-1 Secretion After Meal Ingestion	Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion	300 min	No
Secondary	Insulin Secretion After Ingestion of Meal	Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion	300 min	No