Diabetes Complications
Conditions
Keywords
pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability
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.
Interventions
DRUGPyridostigmine
Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
DRUGPlacebo
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| autonomic modulation assessed by heart rate variability | 1 day |
Countries
Brazil
Outcome results
None listed