CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Sitagliptin +4 moredrug
Likely dose
Valsartan 160mgfrom 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/NCT02639637
NCT02639637Phase 4Completed

Contribution of Neuropeptide Y (NPY) to Vasoconstriction and Sympathetic Activation in the Setting of Dipeptidyl Peptidase IV (DPP4) Inhibition

Vanderbilt University·interventional·Posted Dec 24, 2015·Updated Aug 27, 2018

In Brief

A Phase 4 clinical trial evaluating Sitagliptin, Placebo, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The purpose of this study is to understand how dipeptidyl peptidase IV (DPP4) inhibition in diabetics affects hemodynamic parameters and sympathetic activation in the setting of increasing concentrations of neuropeptide Y, an endogenous peptide. The central hypothesis is that DPP4 inhibition decreases degradation of neuropeptide Y, resulting in increased vasoconstriction and sympathetic activation.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 24, 2015
Enrollment StartDec 1, 2015
Primary CompletionJun 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.5 years ago

Interventions

Sitagliptindrug

Subjects will receive sitagliptin 100 mg daily for 7 days prior to one of the study days.

Placebodrug

Subjects will receive a placebo capsule daily for 7 days prior to one of the study days.

Neuropeptide Ydrug

During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.

Enalaprilatdrug

Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second infusion of neuropeptide Y will begin. Similar to the previous neuropeptide infusion, four doses of neuropeptide Y will be used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.

Valsartan 160mgdrug

Valsartan 160 mg/d for 7 days prior to one of the study days.