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ISRCTN
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ISRCTN84749320
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ClinicalTrials.gov identifier
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Public title
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Prepubertal insulin sensitisation in girls with a combined history of low birthweight and precocious pubarche
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Scientific title
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Acronym
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P&M
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Serial number at source
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N/A
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Study hypothesis
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Insulin sensitisation delays pubertal onset in low birthweight girls with precocious pubarche.
Please note that as of 11/07/2008, this trial has been updated. All updates can be found in the relevant field under the update date.
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Lay summary
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Ethics approval
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Added 11/07/2008:
Ethics approval received from the Comité de Recerca, Hospital Sant Joan de Déu, University of Barcelona (Spain) on the 11th April 2001. The original protocol was also approved by the Agencia Española del Medicamento (ref: 01-0056, code HSJD-LIT-01). An amendment was presented in January 2008; the absence of reply from the administration implies approval.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Precocious pubarche
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Participants - inclusion criteria
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Girls with a combined history of low birthweight (less than 1.5 standard deviation score [SDS]) and precocious pubarche (appearance of pubic hair before age 8)
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Participants - exclusion criteria
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1. Congenital adrenal hyperplasia
2. Diabetes mellitus
3. Thyroid dysfunction
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Anticipated start date
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10/10/2002
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Anticipated end date
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10/10/2007
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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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38
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Interventions
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Randomised subgroups:
1. Metformin 425 mg/day
2. Untreated
Added as of 11/07/2008:
Cross-over of therapy from year 6 of follow-up. All patients have been off therapy from year 5 (July 2007) to year 6.
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Primary outcome measure(s)
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Onset of puberty, measured at baseline and every 6 months (timepoints added 11/07/2008)
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Secondary outcome measure(s)
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1. Menarche, measured baseline and every 6 months. All untreated girls are already menarcheal, 14 of 19 treated girls are mernarcheal.
2. Final height, measured end of the 6th year
Timepoints added 11/07/2008
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Sources of funding
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Hospital Sant Joan de Déu (Spain)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/15356029
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Contact name
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Prof
Lourdes
Ibanez
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Address
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Hospital Sant Joan de Deu
University of Barcelona
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City/town
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Esplugues, Barcelona
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Zip/Postcode
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08950
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Country
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Spain
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Sponsor
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Hospital Sant Joan de Deu (Spain)
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Address
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University of Barcelona
Passeig de Sant Joan de Deu, 2
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City/town
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Esplugues, Barcelona
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Zip/Postcode
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08950
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Country
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Spain
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Sponsor website:
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http://www.hsjd.org
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Date applied
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11/08/2005
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Last edited
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11/07/2008
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Date ISRCTN assigned
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05/10/2005
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