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

NCT ID: NCT00885638

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-09-30

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).

Conditions

Healthy; Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

A placebo tablet is given before ingestion of macronutrients

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

A placebo tablet is given before ingestion of macronutrients

Sitagliptin

Sitagliptin is given before ingestion of macronutrients

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

100 mg sitagliptin before ingestion of macronutrient

Interventions

Sitagliptin

100 mg sitagliptin before ingestion of macronutrient

Intervention Type: DRUG

placebo

A placebo tablet is given before ingestion of macronutrients

Intervention Type: DRUG

Other Intervention Names

Januvia

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Any disease
• Any medication

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Bo Ahren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Ahrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Department of Clinical Sciences Lund, Lund University

Lund, , Sweden

Countries

Sweden

References

Carr RD, Larsen MO, Winzell MS, Jelic K, Lindgren O, Deacon CF, Ahren 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.

Reference Type: BACKGROUND

PMID: 18612044 (View on PubMed)

Ohlsson L, Alsalim W, Carr RD, Tura A, Pacini G, Mari A, Ahren B. Glucose-lowering effect of the DPP-4 inhibitor sitagliptin after glucose and non-glucose macronutrient ingestion in non-diabetic subjects. Diabetes Obes Metab. 2013 Jun;15(6):531-7. doi: 10.1111/dom.12062. Epub 2013 Feb 7.

Reference Type: DERIVED

PMID: 23331498 (View on PubMed)

Other Identifiers

Lund University Diabetes 001

Identifier Type: -

Identifier Source: org_study_id