Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Diabetes Complications Clinical Trial

Official title:

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953914
• Other study ID #: 04471
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: July 6, 2011
• Start date: March 2005
• Est. completion date: May 2010

Study information

• Verified date: July 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications

Intervention

Drug:
• Pyridostigmine
Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
• Placebo
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	autonomic modulation assessed by heart rate variability		1 day	No