Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000291088
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
12/04/2010
Date last updated
12/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
effect of alpha lipoic acid on cardiac autonomic function and platelet reactivity in type I diabetes
Scientific title
In patients with type I diabetes is alpha lipoic acid better than placebo for improvement of cardiac autonomic function and reduction of platelet reactivity?
Secondary ID [1] 1588 0
nil
Universal Trial Number (UTN)
Trial acronym
AUTO-REACT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular autonomic neuropathy in type I diabetes 257115 0
increased platelet reactivity in Type I diabetes 257116 0
Condition category
Condition code
Cardiovascular 257267 257267 0 0
Coronary heart disease
Metabolic and Endocrine 257272 257272 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
alpha lipoic acid
dose: 800 mg once per day
duration of administration: 4 weeks
mode of administration: oral capsules
Intervention code [1] 256278 0
Treatment: Drugs
Comparator / control treatment
placebo
type: 800 mg microcellulose pill
frequency and duration of administration: once daily for 4 weeks
mode of administration: oral capsules
Control group
Placebo

Outcomes
Primary outcome [1] 258186 0
platelet reactivity
assessment method: platelet function analyser system [PFA-100] method and flow cytometry.
Timepoint [1] 258186 0
at baseline and 4 weeks following randomisation
Primary outcome [2] 258187 0
cardiac autonomic function
assessment method: heart rate variability
Timepoint [2] 258187 0
at baseline and 4 weeks following randomisation
Secondary outcome [1] 263820 0
C-reactive protein
assessment method: blood analysis
Timepoint [1] 263820 0
at baseline and 4 weeks following randomisation

Eligibility
Key inclusion criteria
type I diabetes
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiac ischemia
inflammatory diseases
neoplastic and hematologic diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2575 0
Italy
State/province [1] 2575 0
Rome

Funding & Sponsors
Funding source category [1] 256783 0
University
Name [1] 256783 0
Department of Cardiology Catholic University
Country [1] 256783 0
Italy
Primary sponsor type
University
Name
Catholic University
Address
Largo A. Gemelli 8
00168 Rome
Country
Italy
Secondary sponsor category [1] 256059 0
None
Name [1] 256059 0
Address [1] 256059 0
Country [1] 256059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258801 0
Catholic University Ethics Committee
Ethics committee address [1] 258801 0
Largo A. Gemelli 8
00168 Rome
Ethics committee country [1] 258801 0
Italy
Date submitted for ethics approval [1] 258801 0
Approval date [1] 258801 0
Ethics approval number [1] 258801 0

Summary
Brief summary
The present randomized study will evaluate the effect of alpha lipoic acid compared to placebo on cardiac autonomic function and platelet reactivity in type I diabetic patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31031 0
Address 31031 0
Country 31031 0
Phone 31031 0
Fax 31031 0
Email 31031 0
Contact person for public queries
Name 14278 0
Eliano Navarese
Address 14278 0
Largo A. Gemelli 8
00168 Rome
Country 14278 0
Italy
Phone 14278 0
+39 06 3015 4187
Fax 14278 0
Email 14278 0
[email protected]
Contact person for scientific queries
Name 5206 0
Giuseppe Scavone
Address 5206 0
Largo A. Gemelli 8
00168 Rome
Country 5206 0
Italy
Phone 5206 0
+39 063015 4071
Fax 5206 0
Email 5206 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of alpha lipoic acid on cardiac autonomic dysfunction and platelet reactivity in type 1 diabetes: Rationale and design of the AUTOnomic function and platelet REACTivity trial (AUTO-REACT protocol).2011https://dx.doi.org/10.1016/j.diabres.2010.09.003
N.B. These documents automatically identified may not have been verified by the study sponsor.