CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Sitagliptin +1 moredrug
Likely dose
Sitagliptin 100 mgfrom 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/NCT02122380
NCT02122380Phase 4Completed

The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome

Vanderbilt University·interventional·Posted Apr 24, 2014·Updated May 8, 2020

In Brief

A Phase 4 clinical trial evaluating Sitagliptin and Placebo for Polycystic Ovary Syndrome. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit diminished growth hormone (GH) secretion; the latter further contributes to the development of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will enhance GH secretion and vascular function while improving glucose tolerance in patients with impaired GH secretion who are at risk for the development of diabetes mellitus and cardiovascular disease, specifically obese women with polycystic ovary syndrome.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 24, 2014
Enrollment StartFeb 1, 2016
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.2 years ago

Interventions

Sitagliptindrug

Sitagliptin 100 mg by mouth daily for 30 Days

Placebodrug

1 placebo pill by mouth per day for 30 days