drugset / Trial / NCT00597480
Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH)
Phase 4
Terminated
10 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2012-01
- Completion
- 2012-01
Outcome
Outcome not reported
Stopped: “no more inclusions”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Norditropine SimpleXx® | Protein / enzyme biologic | 0.067 mg/kg | — |