NCT03031834

Brief Summary

Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

January 12, 2017

Last Update Submit

January 24, 2017

Conditions

Diabetic Autonomic Neuropathy

Outcome Measures

Primary Outcomes (4)

  • Changes in R-R variation during deep breathing

    2 years

  • Changes in response to Valsalva maneuver

    2 years

  • Changes in 30:15 ratio

    2 years

  • Changes in blood pressure response to standing

    2 years

Interventions

QuinaprilDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus with both autonomic and peripheral neuropathy

You may not qualify if:

  • Hypertension, coronary heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Quinapril

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 26, 2017

Study Start

January 1, 1999

Primary Completion

May 1, 2001

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share