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Effect of DPP4 Inhibition on Vasoconstriction

NCT02639637 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-27

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin

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

DRUG

Placebo

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

DRUG

Neuropeptide Y

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.

DRUG

Enalaprilat

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.

DRUG

Valsartan 160mg

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

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Nancy J Brown, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639637 on ClinicalTrials.gov