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ISRCTN
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ISRCTN74096908
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DOI
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10.1186/ISRCTN74096908
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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INOSIDEX study: to determine whether the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women
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Scientific title
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A randomised trial to determine whether the the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women
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Acronym
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INOSIDEX
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Serial number at source
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02
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Study hypothesis
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It is hypothesised that the inositol improves insulin sensitivity since it works as a second messenger that may achieve an insulin like effect on metabolic enzymes. Inositol combined with alpha lipoic acid can be used as a dietary supplement in insulin resistant patients in order to increase their insulin sensitiveness. Inositol is a vitamin B complex constituent that rules as second messenger in insulin pathway. Alpha lipoic acid is a fatty acid playing a leading role in the cellular energetic metabolism exerting antioxidant activities on free radicals, promoting glucose cellular intake, taking part in fat catabolism on Krebs cycle. Post-menopausal women are often affected by MS and show the highest incidence of breast cancer in the female population. Breast cancer is also associated with adverse outcomes in patients with metabolic syndrome phenotype.
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Lay summary
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Lay summary under review 2
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Ethics approval
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National Cancer Institute of Naples, Scientific and Ethics Committee, 15 September 2011
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Study design
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Prospective randomized controlled study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Optimum control of insulin resistance and lipid profile in post-menopausal women
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Participants - inclusion criteria
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1. Post-menopausal women affected by metabolic syndrome at any age participating to our clinical-instrumental program of surveillance for breast cancer prevention
2. Willing to be assigned to any of the study intervention groups
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Participants - exclusion criteria
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1. Women taking oral hypoglycemic drugs or insulin
2. Women taking statins
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Anticipated start date
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16/10/2011
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Anticipated end date
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16/09/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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155
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Interventions
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The study has involved 155 postmenopausal women with metabolic syndrome recruited at visit for clinical-instrumental surveillance program for breast cancer prevention within National Cancer Institute of Naples.
All women were asked to follow a low calories diet and were assigned randomly to receive daily combination of 4gram of inositol and alpha lipoic acid or placebo for six months.
Blood samples and anthropometric measures were taken at baseline and at six months.
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Primary outcome measure(s)
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1. Reduction of more than 20% of HOMA-IR index and of triglycerides
2. Improvement of high density lipoprotein cholesterol
3. Reduction of anthropometric features such as body mass index, waist and hip ratio
Measured at at baseline and at six months.
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Secondary outcome measure(s)
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Good control of metabolic syndrome helping diet results with insulin sensitizing supplements
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Sources of funding
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1. National Cancer Institute of Naples (Italy)
2. Pharma Dancan s.r.l. (Italy)
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Trial website
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Publications
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Contact name
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Dr
Immacolata
Capasso
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Address
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National Cancer Insitute of Naples
Fondazione G. Pascale
Via Cappella dei Cangiani
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City/town
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Naples
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Zip/Postcode
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80131
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Country
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Italy
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Tel
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+39 081 590 3381
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Email
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icapasso@tiscali.it
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Sponsor
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Pharma Dancan s.r.l. (Italy)
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Address
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c/o Danilo Arnone
Via B. Cavallino, 74
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City/town
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Naples
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Zip/Postcode
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80128
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Country
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Italy
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Tel
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+39 334 184 3758
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Email
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d.arnone@pharmadancan.it
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Date applied
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04/10/2012
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Last edited
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04/02/2013
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Date ISRCTN assigned
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04/01/2013
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