Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
Not Applicable
Completed
- Conditions
- Diabetes Complications
- Interventions
- Drug: Placebo
- Registration Number
- NCT00953914
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pyridostigmine Pyridostigmine - Placebo Placebo If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.
- Primary Outcome Measures
Name Time Method autonomic modulation assessed by heart rate variability 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil