Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Diabetes Complications

Treatments: Drug: Pyridostigmine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00953914

04471

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Pyridostigmine

Experimental group

Treatment:

Drug: Pyridostigmine

Placebo

Placebo Comparator group

Description:

If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.

Treatment:

Drug: Placebo