Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) (SGA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00597480 |
Recruitment Status
:
Terminated
(no more inclusions)
First Posted
: January 18, 2008
Last Update Posted
: April 21, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small for Gestational Age | Drug: rhGH (Norditropine SimpleXx®) Drug: rhGH norditropine simple Xx | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
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)
|
- 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 ]
- Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI) [ Time Frame: every three months during ]
- Polymorphisms of different genes of the signaling pathway of GH and insulin [ Time Frame: the day of inclusion ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597480
France | |
Hopital Saint Vincent de Paul | |
Paris, France, 75014 |
Principal Investigator: | Cecile Teinturier, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00597480 History of Changes |
Other Study ID Numbers: |
P070303 |
First Posted: | January 18, 2008 Key Record Dates |
Last Update Posted: | April 21, 2015 |
Last Verified: | April 2014 |
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 |