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Trial registered on ANZCTR
Registration number
ACTRN12610000458033
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
4/06/2010
Date last updated
4/06/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
Grape skin extract versus placebo in patients with metabolic syndrome and insulin resistance. A double blind, randomized, multicenter study.
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Scientific title
In adults with metabolic syndrome, is grape skin extract combined with diet/exercise orientation effective in insulin resistance (measured using the homeostasis model assessment of insulin resistance [HOMA-IR] index), as compared to placebo plus diet/exercise orientation?
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Secondary ID [1]
251890
0
none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome
257481
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Condition category
Condition code
Metabolic and Endocrine
257633
257633
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Two arms:
1)grape skin extract 500 micrograms, three times a day, for 24 weeks; tablet
2)placebo (microcellulose) 500 micrograms, three times a day, for 24 weeks; tablet
Both arms will have non-pharmacological treatment (specialised diet taken daily for 24 weeks/exercise orientation: regular light/moderate-intensity physical activity at least 30 minutes daily, 4-7 days/week) according to the First Brazilian Guideline on the Diagnosis and Treatment of The metabolic Syndrome- Brazilian Society of Cardiology
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Intervention code [1]
256579
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Treatment: Drugs
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Comparator / control treatment
placebo (microcellulose).
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Control group
Placebo
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Outcomes
Primary outcome [1]
258543
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insulin resistance measured by the homeostasis model assessment of insulin resistance [HOMA-IR] index
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Assessment method [1]
258543
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Timepoint [1]
258543
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all visits
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Secondary outcome [1]
264386
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blood pressure (using a calibrated sphygmomanometer)
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Assessment method [1]
264386
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Timepoint [1]
264386
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all visits
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Secondary outcome [2]
264387
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lipids: high-density lipoprotein [HDL-c], low-density lipoprotein [LDL-c], total cholesterol, triglycerides (blood analysis)
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Assessment method [2]
264387
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Timepoint [2]
264387
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all visits
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Eligibility
Key inclusion criteria
diagnosis of metabolic syndrome
homeostasis model assessment of insulin resistance [HOMA-IR] >2,7
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
hypertension (stages 2 and 3)
diabetes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/08/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
128
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2674
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Brazil
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State/province [1]
2674
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Funding & Sponsors
Funding source category [1]
257075
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Commercial sector/Industry
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Name [1]
257075
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Ache Laboratories
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Address [1]
257075
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Rodovia Dutra km 222,2 Guarulhos, State of Sao Paulo Brazil CEP (ZIP) 07034-904
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Country [1]
257075
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Brazil
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Primary sponsor type
Commercial sector/Industry
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Name
Ache Laboratories
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Address
Rodovia Dutra km 222,2 Guarulhos, State of Sao Paulo Brazil CEP (ZIP) 07034-904
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Country
Brazil
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Secondary sponsor category [1]
256333
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None
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Name [1]
256333
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N/A
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Address [1]
256333
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N/A
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Country [1]
256333
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
In adults with metabolic syndrome the study will compare the efficacy of a grape skin extract combined with non-pharmacological treatment (diet/exercise orientation) in insulin resistance (measured using the homeostasis model assessment of insulin resistance [HOMA-IR] index), as compared to placebo plus non-pharmacological treatment (diet/exercise orientation). The hypothesis will consider the superiority of the grape skin extract therapy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31238
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Address
31238
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Country
31238
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Phone
31238
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Fax
31238
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Email
31238
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Contact person for public queries
Name
14485
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Fabio Ikedo
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Address
14485
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Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
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Country
14485
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Brazil
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Phone
14485
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55-11-26088181
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Fax
14485
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Email
14485
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[email protected]
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Contact person for scientific queries
Name
5413
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Fabio Ikedo
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Address
5413
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Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
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Country
5413
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Brazil
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Phone
5413
0
55-11-26088181
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Fax
5413
0
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Email
5413
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[email protected]
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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
No additional documents have been identified.
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