Text Size

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00953914
First received: August 4, 2009
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Diabetes Complications
 Drug: Pyridostigmine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • autonomic modulation assessed by heart rate variability [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: May 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953914

Locations
Brazil
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
  More Information

Publications:

Responsible Party: Ruy Silveira Moraes Filho, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00953914     History of Changes
Other Study ID Numbers: 04471
Study First Received: August 4, 2009
Last Updated: July 6, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
pyridostigmine
autonomic modulation
diabetes mellitus
heart rate variability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pyridostigmine Bromide
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013