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

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ClinicalTrials.gov Identifier: NCT00885638

Recruitment Status : Completed

First Posted : April 22, 2009

Results First Posted : January 15, 2013

Last Update Posted : January 30, 2014

Sponsor:

Information provided by (Responsible Party):

Bo Ahren, Lund University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Healthy Type 2 Diabetes	Drug: Sitagliptin Drug: placebo	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Non-Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers
Study Start Date :	August 2009
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	September 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo A placebo tablet is given before ingestion of macronutrients	Drug: placebo A placebo tablet is given before ingestion of macronutrients
Active Comparator: Sitagliptin Sitagliptin is given before ingestion of macronutrients	Drug: Sitagliptin 100 mg sitagliptin before ingestion of macronutrient Other Name: Januvia

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Insulin Secretion After Ingestion of Meal [ Time Frame: 300 min ]
Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 30 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any disease
Any medication

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885638

Locations

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Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84

Sponsors and Collaborators

Lund University

Investigators

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Principal Investigator:	Bo Ahrén, MD, PhD	Lund University

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ohlsson L, Alsalim W, Carr RD, Tura A, Pacini G, Mari A, Ahrén 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.

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Responsible Party:	Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier:	NCT00885638
Other Study ID Numbers:	Lund University Diabetes 001
First Posted:	April 22, 2009 Key Record Dates
Results First Posted:	January 15, 2013
Last Update Posted:	January 30, 2014
Last Verified:	December 2013

Keywords provided by Bo Ahren, Lund University:


GLP-1 Insulin secretion Macronutrients

Additional relevant MeSH terms:

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Sitagliptin Phosphate Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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