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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT00885638
First received: April 21, 2009
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Healthy
Type 2 Diabetes
 Drug: Sitagliptin
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Glucagon-like Peptide-1 Secretion After Meal Ingestion [ Time Frame: 300 min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion


Enrollment: 12
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885638

Locations
Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Sponsors and Collaborators
Lund University
  More Information

Publications:

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT00885638     History of Changes
Other Study ID Numbers: Lund University Diabetes 001
Study First Received: April 21, 2009
Results First Received: September 21, 2012
Last Updated: December 7, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
GLP-1
Insulin secretion
Macronutrients

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013