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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00120497 |
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Date of registration:
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13/07/2005 |
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Primary sponsor: |
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Public title:
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Study to Examine Insulin Resistance During Growth Hormone Treatment for Short Stature Due to Low Birthweight
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Scientific title:
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Growth Hormone and Insulin Resistance in Children With Intrauterine Growth Restriction |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00120497 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Crossover, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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David B Rhoads, PhD |
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Address:
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Telephone:
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617-724-2707 |
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Email:
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rhoads@helix.mgh.harvard.edu |
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Affiliation:
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Name:
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Lynne L Levitsky, MD |
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Address:
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Telephone:
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617-726-2909 |
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Email:
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llevitsky@partners.org |
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Affiliation:
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Name:
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Lynne L Levitsky, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- height < 5%-ile
- birthweight < 10%-ile for gestational age
- gestation: = 36 weeks
- male or female
- age: 8-12 years
- BMI = 10-90%-ile
- normal childhood activity, no physical or other limitations
- bone age = 12 years
- normal, balanced diet (20-40% calories from fat)
Exclusion Criteria:
- puberty (beyond Tanner Stage 1)
- diabetes in subject or first degree relative
- sex steroid therapy
- chronic conditions requiring medication
- other causes of short stature (e.g., Prader-Willi, intracranial lesions,
hypopituitarism, Turner syndrome, GHD, etc.)
- significant systemic disease (pulmonary, cardiac, renal, or other)
- non-removable metal
- other conditions judged by the investigator to pose a hazard (including history of
neoplasm)
- simultaneous participation in another medical investigation or trial
Age minimum:
8 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fetal Growth Retardation
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Intervention(s)
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Drug: somatropin (rDNA)
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Secondary ID(s)
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2005P-000384
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IRG 2004-0964
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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