Diabetes ComplicationsNCT00953914
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients
A study testing Pyridostigmine in people with Diabetes Complications, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Pyridostigmine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2005to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus
Who cannot join
- myocardial infarction
- acute ischemic syndromes
- second or third degree atrioventricular block
- active alcoholism
- thyroid dysfunction
- chronic obstructive pulmonary disease
- history of intolerance to pyridostigmine.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
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.
Read the 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.
- Conditions
- Diabetes Complications
- Being tested
- Pyridostigmine, Placebo
- Keywords
- pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyridostigmineDrug
Pills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day.
PlaceboDrug
If subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Pyridostigmine | Experimental | Not described Receives: Drug: Pyridostigmine |
| Placebo | Placebo comparator | If a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomic modulation assessed by heart rate variability
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2005
- Primary completionJul 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Ruy S. Moraes, MD, Phd, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953914
- Sponsor's protocol ID
- 04471
- Status last verified
- Jul 2011
- First submitted
- 4 Aug 2009
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12947369
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients With Autonomic Neuropathy
- ClinicalTrials.gov ID
- NCT00953914
- Acronym / sponsor ID
- 04471
- Conditions
- Diabetes Complications
- Keywords
- pyridostigmine, autonomic modulation, diabetes mellitus, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridostigmine | Experimental | Drug: Pyridostigmine |
| Placebo | Placebo comparator | Drug: PlaceboIf a subject is randomized to placebo, he will receive placebo pills 3 times daily for 1 day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetes mellitus
Key exclusion criteria (7 listed)
- myocardial infarction
- acute ischemic syndromes
- second or third degree atrioventricular block
- active alcoholism
- thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyridostigminePills containing 30 mg of Pyridostigmine will be orally administered 3 times daily for 1 day. | Drug | Pyridostigmine |
| PlaceboIf subject is randomized to placebo, placebo pills will give 30 mg orally 3 times daily for 2 days | Drug | Placebo |
Primary outcome
autonomic modulation assessed by heart rate variability
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Background: PubMed 12947369Behling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruy S. Moraes, MD, Phd principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyridostigmine in people with Diabetes Complications, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autonomic modulation assessed by heart rate variability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.