NCT00953914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

4.3 years

First QC Date

August 4, 2009

Last Update Submit

July 6, 2011

Conditions

Diabetes Complications

Keywords

pyridostigmineautonomic modulationdiabetes mellitusheart rate variability

Outcome Measures

Primary Outcomes (1)

  • autonomic modulation assessed by heart rate variability

    1 day

Study Arms (2)

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

PyridostigmineDRUG

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

Pyridostigmine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus

You may not qualify if:

  • myocardial infarction
  • acute ischemic syndromes
  • second or third degree atrioventricular block
  • active alcoholism
  • thyroid dysfunction
  • chronic obstructive pulmonary disease
  • history of intolerance to pyridostigmine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 12947369BACKGROUND

MeSH Terms

Conditions

Diabetes ComplicationsDiabetes Mellitus

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ruy S. Moraes, MD, Phd

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

March 1, 2005

Primary Completion

July 1, 2009

Study Completion

May 1, 2010

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

BR(1)