Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Complications
Intervention: Pyridostigmine (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
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, 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
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: July 6, 2011
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