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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

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 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


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




Primary Outcome Measures :
  1. 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 :
  1. 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



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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

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
Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bo Ahrén, MD, PhD Lund University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT00885638     History of Changes
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:
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