Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy|
- autonomic modulation assessed by heart rate variability [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||May 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953914
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil|
|Principal Investigator:||Ruy S. Moraes, MD, Phd||Hospital de Clínicas de Porto Alegre|