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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.
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?
Secondary ID [1] 251890 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 257481 0
Condition category
Condition code
Metabolic and Endocrine 257633 257633 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 256579 0
Treatment: Drugs
Comparator / control treatment
placebo (microcellulose).
Control group
Placebo

Outcomes
Primary outcome [1] 258543 0
insulin resistance measured by the homeostasis model assessment of insulin resistance [HOMA-IR] index
Timepoint [1] 258543 0
all visits
Secondary outcome [1] 264386 0
blood pressure (using a calibrated sphygmomanometer)
Timepoint [1] 264386 0
all visits
Secondary outcome [2] 264387 0
lipids: high-density lipoprotein [HDL-c], low-density lipoprotein [LDL-c], total cholesterol, triglycerides (blood analysis)
Timepoint [2] 264387 0
all visits

Eligibility
Key inclusion criteria
diagnosis of metabolic syndrome
homeostasis model assessment of insulin resistance [HOMA-IR] >2,7
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hypertension (stages 2 and 3)
diabetes

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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 2674 0
Brazil
State/province [1] 2674 0

Funding & Sponsors
Funding source category [1] 257075 0
Commercial sector/Industry
Name [1] 257075 0
Ache Laboratories
Country [1] 257075 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Ache Laboratories
Address
Rodovia Dutra km 222,2 Guarulhos, State of Sao Paulo Brazil CEP (ZIP) 07034-904
Country
Brazil
Secondary sponsor category [1] 256333 0
None
Name [1] 256333 0
N/A
Address [1] 256333 0
N/A
Country [1] 256333 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31238 0
Address 31238 0
Country 31238 0
Phone 31238 0
Fax 31238 0
Email 31238 0
Contact person for public queries
Name 14485 0
Fabio Ikedo
Address 14485 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 14485 0
Brazil
Phone 14485 0
55-11-26088181
Fax 14485 0
Email 14485 0
fabio.ikedo@ache.com.br
Contact person for scientific queries
Name 5413 0
Fabio Ikedo
Address 5413 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 5413 0
Brazil
Phone 5413 0
55-11-26088181
Fax 5413 0
Email 5413 0
fabio.ikedo@ache.com.br

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.