CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Sitagliptin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01701973
NCT01701973Phase 4Completed

The Effect of Dipeptidyl Peptidase IV Inhibition on Growth Hormone-Mediated Vasodilation

Vanderbilt University·interventional·Posted Oct 5, 2012·Updated May 29, 2018

In Brief

A Phase 4 clinical trial evaluating Sitagliptin, Pegvisomant, and 3 other interventions for Obesity. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This study tests the following hypotheses: Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone releasing hormone (GHRH). Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition will result in an increase in endothelium-dependent vasodilation mediated by GH and independent from GLP1 (glucagon like peptide-1) in healthy lean adults. This study promises to provide novel data regarding how this increasingly used class of anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation. Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study may evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with obesity and pre-diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.7 years ago

Interventions

Sitagliptindrug

During Aim 1, given on one of two study days (other study day subjects receive placebo.) During Aim 2, given during both of two study days.

Pegvisomantdrug

During Aim 2, given 72 hours prior to one of two study days (Group B subjects only)

Placebodrug

During Aim 1, given on one of two study days (other study day subjects receive sitagliptin.) During Aim 2, given on one of two study days (other study day subjects receive either L-NMMA, pegvisomant, or Exendin 9-39 pending their group assignment)

L-NMMAdrug

During Aim 2, given during one of two study days (Group A subjects only)

Exendin 9-39drug

During Aim 2, given during one of two study days (Group C subjects only)