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Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Primary Purpose

Diabetes Complications

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pyridostigmine
Placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pyridostigmine

Placebo

Arm Description

If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.

Outcomes

Primary Outcome Measures

autonomic modulation assessed by heart rate variability

Secondary Outcome Measures

Full Information

First Posted
August 4, 2009
Last Updated
July 6, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT00953914
Brief Title
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
Official Title
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyridostigmine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.
Intervention Type
Drug
Intervention Name(s)
Pyridostigmine
Intervention Description
Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
Primary Outcome Measure Information:
Title
autonomic modulation assessed by heart rate variability
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruy S. Moraes, MD, Phd
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12947369
Citation
Behling A, Moraes RS, Rohde LE, Ferlin EL, Nobrega AC, Ribeiro JP. Cholinergic stimulation with pyridostigmine reduces ventricular arrhythmia and enhances heart rate variability in heart failure. Am Heart J. 2003 Sep;146(3):494-500. doi: 10.1016/S0002-8703(03)00319-3.
Results Reference
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Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

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