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

This study has been terminated.
(no more inclusions)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00597480
First received: January 7, 2008
Last updated: April 20, 2015
Last verified: April 2014
History of Changes
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA [ Time Frame: every three months during twenty seven months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI) [ Time Frame: every three months during ] [ Designated as safety issue: Yes ]
  • Polymorphisms of different genes of the signaling pathway of GH and insulin [ Time Frame: the day of inclusion ] [ Designated as safety issue: No ]
Enrollment: 10
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
the recommended dose in the EU of rhGH (Norditropine SimpleXx®)
 Drug: rhGH (Norditropine SimpleXx®)
the recommended dose in the EU of rhGH (Norditropine SimpleXx®
Active Comparator: 2
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
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)

Detailed Description:

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:

  • Quantify the metabolic effects of rhGH treatment by analyzing insulin levels, insulin sensitivity and lipid profile (lipolysis and ketogenesis);
  • Evaluate the effects of two different rhGH regimens on the growth of children born SGA;
  • Determine if the metabolic effects of rhGH therapy correlate to the growth responses in the two groups;
  • Identify factors, especially genetic factors, responsible for the variations in individual metabolic and growth-promoting effects of rhGH in children born SGA.

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.

  Eligibility
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597480

Locations
France
Hopital Saint Vincent de Paul
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Cecile Teinturier, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00597480     History of Changes
Other Study ID Numbers: P070303 
Study First Received: January 7, 2008
Last Updated: April 20, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Growth hormone
Child
insulin resistance
metabolic syndrome X
children born small for gestational age

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016