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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers

Conditions
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Healthy, Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men Age 20-30 years BMI 20-30 kg/m2 Exclusion Criteria: Any disease Any medication

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A placebo tablet is given before ingestion of macronutrients | Drug: placebo<br>* A placebo tablet is given before ingestion of macronutrients<br>|
| Active Comparator: Sitagliptin<br>Sitagliptin is given before ingestion of macronutrients | Drug: Sitagliptin<br>* 100 mg sitagliptin before ingestion of macronutrient<br>* Other names: Januvia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion After Ingestion of Meal | Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion | 300 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, Insulin secretion, Macronutrients