ClinicalTrials.gov
ClinicalTrials.gov Menu

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

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.
ClinicalTrials.gov Identifier: NCT00953914
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : March 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. autonomic modulation assessed by heart rate variability [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

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

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 Posted: August 6, 2009    Key Record Dates
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