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

NCT00597480 | Terminated Phase 4 DMC

• 1 other identifier: P070303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small for Gestational Age

Keywords

Growth hormone; Child; insulin resistance; metabolic syndrome X; children born small for gestational age

Outcome Measures

Primary Outcomes (1)

• Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA

  every three months during twenty seven months

Secondary Outcomes (2)

• Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI)

  every three months during

• Polymorphisms of different genes of the signaling pathway of GH and insulin

  the day of inclusion

Study Arms (2)

1

ACTIVE COMPARATOR

the recommended dose in the EU of rhGH (Norditropine SimpleXx®)

Drug: 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)

Drug: rhGH norditropine simple Xx

Interventions

rhGH (Norditropine SimpleXx®) DRUG

the recommended dose in the EU of rhGH (Norditropine SimpleXx®

1

rhGH norditropine simple Xx DRUG

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)

2

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prepubertal age
• Prepubertal characteristics
• Non GH deficient
• Short children (height \< -2.5 SDS)
• Born SGA (birth height \< -2 SDS)
• Parental height adjusted (\< -1 DS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Saint Vincent de Paul

Paris, 75014, France

Location

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cecile Teinturier, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 18, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)