Pyridostigmine and Its Effects on Autonomic Modulation in... | NCT00953914

Studies
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

NCT00953914

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Jul 7, 2011Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Diabetes Complications

Interventions

Pyridostigmine
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Jul 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Aug 4, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pyridostigmine	Experimental		Drug: Pyridostigmine
Placebo	Placebo Comparator	If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pyridostigmine	Drug	Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.	Pyridostigmine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
autonomic modulation assessed by heart rate variability		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruy S. Moraes, MD, Phd	Hospital de Clínicas de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12947369	Background	Behling A, Moraes RS, Rohde LE, Ferlin EL, Nobrega 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. doi: 10.1016/S0002-8703(03)00319-3.

ID	Term
D048909	Diabetes Complications
D003920	Diabetes Mellitus

ID	Term
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011726	Pyridinium Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds