Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

January 24, 2017 updated by: Konstantinos Tziomalos, Aristotle University Of Thessaloniki

Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes mellitus with both autonomic and peripheral neuropathy

Exclusion Criteria:

  • Hypertension, coronary heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in R-R variation during deep breathing
Time Frame: 2 years
2 years
Changes in response to Valsalva maneuver
Time Frame: 2 years
2 years
Changes in 30:15 ratio
Time Frame: 2 years
2 years
Changes in blood pressure response to standing
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AristotleUMEDSCH095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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