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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00597480 |
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Condition | Intervention | Phase |
---|---|---|
Small for Gestational Age |
Drug: rhGH (Norditropine SimpleXx®) Drug: rhGH norditropine simple Xx |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study of Growth-Promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH |
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
the recommended dose in the EU of rhGH (Norditropine SimpleXx®)
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Drug: rhGH (Norditropine SimpleXx®)
the recommended dose in the EU of rhGH (Norditropine SimpleXx®
|
2: Active Comparator
the dose to achieve a "treat-to target" value of IGF-1 levels within a +1,5 to +2,5 SDS interval (starting dose, 0,067 mg/kg/day)
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Drug: rhGH norditropine simple Xx
the dose to achieve a "treat-to target" value of IGF-1 levels within a +1,5 to +2,5 SDS interval (starting dose, 0,067 mg/kg/day)
|
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Because rhGH use in this population will sharply increase in the coming years, our purpose is to identify and analyze factors that predispose these children born SGA to the metabolic consequences of rhGH therapy.
The main objective of this study is to identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA. We want to:
This is a randomized, open-labeled, 2-year study, which will compare two regimens of rhGH therapy on the growth responses and metabolic effects in short children born SGA.
100 prepubertal, non GH deficient, short children (height < -3 SDS) born SGA (birth height < -2 SDS) will be randomized to receive either the recommended dose in the EU of rhGH (Norditropine SimpleXx®), or the dose to achieve a "treat-to target" value of IGF-1 levels within a +1,5 to +2,5 SDS interval (starting dose, 0,067 mg/kg/day) for 24 months.
Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI), fasting insulin and glucose levels, HOMA index of insulin resistance, insulin and glucose levels during OGTT, HbA1C and fasting serum lipids (free fatty acids, 3-hydroxybutyrate, total cholesterol, LDL and HDL cholesterol, triglycerides). Height, growth velocity, IGF-1 and IGF-BP3 levels will evaluate growth response of rhGH treatment.
Polymorphisms of different genes of the signaling pathway of GH and insulin will be analyzed in order to search for those possibly responsible for the variability in metabolic and growth responses during rhGH treatment in SGA children.
Ages Eligible for Study: | 4 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pierre BOUGNERES, MD, PHD | 0033140488073 | pierre.bougneres@paris5.inserm.fr |
Contact: Agnès Linglart, MD, PHD | 0033140488084 | linglart@ccr.jussieu.fr |
France | |
Hopital Saint Vincent de Paul | Recruiting |
Paris, France, 75014 | |
Contact: Cécile TEINTURIER, MD 0033158411184 | |
Sub-Investigator: Cecile Teinturier, MD |
Principal Investigator: | Cecile Teinturier, MD | AP-HP |
Responsible Party: | Delegation of Clinical Research ( Yannick VACHER ) |
Study ID Numbers: | P070303 |
Study First Received: | January 7, 2008 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00597480 |
Health Authority: | France: Ministry of Health |
Growth hormone Child insulin resistance metabolic syndrome X children born small for gestational age |
Metabolic Syndrome X Syndrome X Insulin Resistance Insulin Abdominal obesity metabolic syndrome |