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ISRCTN
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ISRCTN65353256
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ClinicalTrials.gov identifier
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Public title
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Biological Variation of insulin resistance in normal ovulating women and PolyCystic Ovarian Syndrome
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Scientific title
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Acronym
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Biological variation in PCOS
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Serial number at source
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02/98/249
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Study hypothesis
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Women with polycystic ovarian syndrome has a higher and more variable insulin resistance than controls
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Ethics approval
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Hull and East Riding Local Research Ethics Committee. LREC number : 02/98/249
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Study design
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Comparison 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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28/02/2002
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Anticipated end date
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31/12/2004
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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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Primary outcome was the comparison of insulin resistance in polycystic ovarian syndrome and controls. Venous blood was taken for measurement of insulin and glucose levels, and insulin resistance was calculated by HOMA-IR (insulin x glucose /22.5).
Secondary outcome was the biological variation of insulin resistance in polycystic ovarian syndrome and controls. Insulin resistance was calculated by HOMA-IR as above, and calculation of biological variation was done on 10 consecutive HOMA-IR taken at 4-day intervals.
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Primary outcome measure(s)
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Comparison of Insulin resistance in polycystic ovarian syndrome and controls
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Secondary outcome measure(s)
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Comparison of biological variation of polycystic ovarian syndrome with controls
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Sources of funding
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Diabetes endowment Fund, University of Hull (UK)
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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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28/02/2007
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Date ISRCTN assigned
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28/02/2007
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