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Completed

NCT Number: NCT00953914

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

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.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pyridostigmine

Drug

Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.

Placebo

Drug

If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days

Primary outcomes

  1. autonomic modulation assessed by heart rate variability

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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