Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00953914
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 62
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications	Drug: Pyridostigmine; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyridostigmine	Drug: Pyridostigmine; 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.	Drug: Placebo; If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

Outcome Measures

Primary Outcome Measures

1. autonomic modulation assessed by heart rate variability [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Brazil

Sponsors and Collaborators

• Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Ruy S. Moraes, MD, Phd, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

• Behling A, Moraes RS, Rohde LE, Ferlin EL, Nóbrega AC, Ribeiro JP. Cholinergic stimulation with pyridostigmine reduces ventricular arrhythmia and enhances heart rate variability in heart failure. Am Heart J. 2003 Sep;146(3):494-500.

• ClinicalTrials.gov Identifier: NCT00953914
• Other Study ID Numbers: 04471
• First Posted: Aug 6, 2009
• Last Update Posted: Jul 7, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: pyridostigmine; autonomic modulation; diabetes mellitus; heart rate variability
• Additional relevant MeSH terms: Diabetes Complications; Pyridostigmine Bromide

Study Results

No Results Posted as of Jul 7, 2011