Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

July 6, 2011 updated by: Hospital de Clinicas de Porto Alegre

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy

The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The reduced heart rate variability is associated with increased risk of death in patients with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart rate variability in normal individuals and congestive heart failure subjects but its effects on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the short-term administration of pyridostigmine bromide increases heart rate variability in patients with diabetes mellitus.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital de Clínicas de Porto Alegre

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetes mellitus

Exclusion Criteria:

  • myocardial infarction
  • acute ischemic syndromes
  • second or third degree atrioventricular block
  • active alcoholism
  • thyroid dysfunction
  • chronic obstructive pulmonary disease
  • history of intolerance to pyridostigmine.

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?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pyridostigmine
Drug: Pyridostigmine
Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
PLACEBO_COMPARATOR: Placebo
If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.
Drug: Placebo
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
autonomic modulation assessed by heart rate variability
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ruy S. Moraes, MD, Phd, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2005

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (ESTIMATE)

August 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04471

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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