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Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953914
First Posted: August 6, 2009
Last Update Posted: July 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  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
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 4, 2009
First Posted: August 6, 2009
Last Update Posted: July 7, 2011
Last Verified: July 2011

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

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