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ISRCTN
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ISRCTN58369615
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ClinicalTrials.gov identifier
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Public title
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Biological variation of insulin resistance on polycystic ovarian syndrome and effect of treatment
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Scientific title
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Biological factors of insulin resistance and cardiovascular risk factors in women with polycystic ovarian syndrome: modification with diet, metformin, pioglitazone and orlistat
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Acronym
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N/A
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Serial number at source
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07/03/117
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Study hypothesis
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To determine if insulin resistance variability and the associated cardiovascular risk factor variability is affected by weight loss aided by the use of diet, orlistat, or by the insulin sensitising agents metformin, pioglitazone or soy in patients with polycystic ovarian syndrome (PCOS).
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Ethics approval
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Ethics approval received from Hull and East Riding Local Research Ethics Committee (ref: 07/03/117).
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Study design
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Prospective study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Polycystic ovarian syndrome
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Participants - inclusion criteria
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The diagnosis of PCOS will be based on evidence of hyperandrogenemia (Free androgen index > 8, with a history of oligomenorrhea and hirsutism or acne. Non classical 21-hydroxylase deficiency, hyperprolactinemia, and androgen secreting tumors will be excluded by appropriate tests before the diagnosis of PCOS will be made. Transvaginal ultrasound will also be performed to confirm the diagnosis of PCOS
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Participants - exclusion criteria
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1. No subjects will be taking any medication currently or for the preceding six months
2. No concurrent illness
3. Patients not wishing to allow disclosure to their GPs
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Anticipated start date
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06/08/2004
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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Treatment with either metformin, orlistat or pioglitazone. Dietary advise was based on the recommendation by the "British Heart Foundation's Guide for Healthy Eating" and for the soy treatment arm, a sachet containing 132 mg of phytoestrogen consisting mainly of genistein and daidzein in 30 g of soy protein was given.
After baseline blood assessments, patients were randomised to either:
1. Dietary advice only
2. Metformin (500mg three times daily)
3. Orlistat (120mg three times daily)
4. Pioglitazone (45mg once daily)
5. Soy phytoestrogen
Duration of treatment was for 3 months after which they came back for phase two of the study where further blood sampling was carried out.
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Primary outcome measure(s)
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Reduction in insulin resistance
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Secondary outcome measure(s)
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Reduction in hyperandrogenaemia
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Sources of funding
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University of Hull (UK) - Diabetes endowment fund
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Trial website
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Publications
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Contact name
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Prof
Stephen
Atkin
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Address
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Centre for Diabetes and Endocrinology
220-236 Anlaby Road
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City/town
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Hull
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Zip/Postcode
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HU3 2RW
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Country
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United Kingdom
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Sponsor
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Hull and East Yorkshire Hospitals NHS Trust (UK)
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Address
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Hull Royal Infirmary
Anlaby Road
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City/town
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Hull
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Zip/Postcode
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HU3 2JZ
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Country
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United Kingdom
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Date applied
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25/01/2007
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Last edited
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07/03/2008
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Date ISRCTN assigned
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28/02/2007
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