Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pyridostigmine

Group Type EXPERIMENTAL

Pyridostigmine

Intervention Type DRUG

Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

Interventions

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Pyridostigmine

Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.

Intervention Type DRUG

Placebo

If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No