Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion
Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers
1 other identifier
interventional
12
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Aug 2009
Longer than P75 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
January 15, 2013
CompletedJanuary 30, 2014
December 1, 2013
1.7 years
April 21, 2009
September 21, 2012
December 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Insulin Secretion After Ingestion of Meal
300 min
Study Arms (2)
Placebo
PLACEBO COMPARATORA placebo tablet is given before ingestion of macronutrients
Sitagliptin
ACTIVE COMPARATORSitagliptin is given before ingestion of macronutrients
Interventions
100 mg sitagliptin before ingestion of macronutrient
Eligibility Criteria
You may qualify if:
- Healthy men
- Age 20-30 years
- BMI 20-30 kg/m2
You may not qualify if:
- Any disease
- Any medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Department of Clinical Sciences Lund, Lund University
Lund, 221 84, Sweden
Related Publications (2)
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.
PMID: 18612044BACKGROUNDOhlsson 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.
PMID: 23331498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Bo Ahrén
- Organization
- Lund University
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Ahrén, MD, PhD
Lund University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 21, 2009
First Posted
April 22, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
September 1, 2012
Last Updated
January 30, 2014
Results First Posted
January 15, 2013
Record last verified: 2013-12