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Completed

NCT Number: NCT00885638

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

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).

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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Sciences Lund, Lund University

Lund, 221 84, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any disease
  • Any medication

Treatment and study plan

Sitagliptin

Drug

100 mg sitagliptin before ingestion of macronutrient

Other names: Januvia

Placebo

Drug

A placebo tablet is given before ingestion of macronutrients

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 22, 2009
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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