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Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Information source: Hospital de Clinicas de Porto Alegre
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Complications

Intervention: Pyridostigmine (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Ruy S. Moraes, MD, Phd, Principal Investigator, Affiliation: Hospital de Clínicas de Porto Alegre

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.

Clinical Details

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: autonomic modulation assessed by heart rate variability

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil; Recruiting
Ruy S Moraes, phd, Phone: 55-51-21018287, Email: rfilho@hcpa.ufrgs.br
Additional Information

Related publications:

Behling A, Moraes RS, Rohde LE, Ferlin EL, Nóbrega 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.

Starting date: March 2005
Last updated: June 2, 2010

Page last updated: October 04, 2010

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