Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH)

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Prepubertal age

• Prepubertal characteristics

• Non GH deficient

• Short children (height < -2.5 SDS)

• Born SGA (birth height < -2 SDS)

• Parental height adjusted (< -1 DS)

• No rhGH treatment before inclusion

Exclusion Criteria:

• ALLERY to rhGH or excipients

• Small height etiologies

• Cancer or cancer treatment ongoing

• Drugs interference with growth

• Mental impairment

• Hypertrophic cardiopathy impairment

• Hypertension not under controlled

• Intra cranial hypertension not controlled

• Diabetes and hyperglycaemia without diabetes

• Dyslipidemia

• Hepatitis

• Kidney failure

• Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome)

• No social security

• State of health in worst conditions after cardiac surgery, polytraumatism