Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00522743
Status:
COMPLETED
Last Update Posted:
2010-07-14
First Post:
2007-08-29
Brief Title:
Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Two Arms Open Controlled Prospective Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA
All subjects will be treated with NorditropinSimplex at a dosage of 100mcgkgd
At onset of puberty subjects will be randomized into either combined treatment with GH and GnRHa or GH alone
All subjects will be treated with NorditropinSimplex at a dosage of 100mcgkgd
At onset of puberty subjects will be randomized into either combined treatment with GH and GnRHa or GH alone
Detailed Description:
A 2-arms randomized open prospective intervention study including 20 boys in order to determine the effect of growth hormone GH and gonadotropin-releasing hormone agonist treatment versus growth hormone GnRHa alone on growth and metabolic response
Objectives
The primary objective is to investigate the effect of delaying the pubertal process by pubertal suppression on growth and final height of boys who were born SGA and treated with GH
The secondary objectives are to determine the metabolic effect of the combined therapy of GH plus gonadotropin agonists to that of GH alone on the dietary intake serum leptin ghrelin IGF-1 lipid and lipoprotein concentrations prior to and during treatment and to assess the quality of life between the two groups
Study population
20 prepubertal boys
Inclusion Criteria
1 Ages 10-13
2 IUGR
3 Height of at least 2 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention CDC
4 prepubertalTanner stage 1 at commencement of trail
5 Peak GH above 10ngml in at least one provocative test for GH secretion
6 Signed informed consent form
Exclusion criteria
1 Growth retardation associated with malignancy severe chronic disease genetic syndromes and endocrine disorders
2 Diabetes
3 Treatment with any medical product which may interfere with GH effects
Trail design
A prospective randomized controlled study assessing the impact of two years of combined treatment with GH and GnRHa on height of boys with severe growth failure due to SGA with height 225 SDS compared with GH alone
All subjects will be treated with NorditropinSimplex at a dosage of 100mcgkgd At onset of puberty testicular volume greater than 4 ml in consecutive examinations subjects will be randomized into either combined treatment with GH and GnRHa or GH alone
Methods
1 Urine test will be held every three months
2 X-ray photograph for bone age determination will be taken at baseline and every year after
3 Blood will be taken at baseline and every year after in order to evaluate the following parameters Lipid and lipoprotein concentrations ghrelin leptin glucose insulin and HbA1c
4 Blood will be taken on randomization visit and three months after in order to evaluated the following parameters LH FSH and Testosterone
5 Blood will be taken at baseline and every half a year after to evaluate levels of IGF-1
6 For evaluation of the growth hormone response additional blood tests will be preformed one month and three months after treatment with growth hormone
7 On every blood and urine that will be taken proteomic analysis will be held
8 Before treatment with growth hormone one year after treatment and in the end of the study quality of life questionnaire appetite questionnaire and Psychological questionnaires will be filled
The safety of growth hormone treatment will be assessed from
1 Monitoring of adverse events
2 Measurement of HbA1c
3 Measurement of hematology serum biochemistry and urinalysis laboratory variables
4 Measurement of fasting glucose and insulin concentrations
5 IGF-1
6 Physical examinations and measurements of vital signs height and body weight
7 Measurement of bone age
Objectives
The primary objective is to investigate the effect of delaying the pubertal process by pubertal suppression on growth and final height of boys who were born SGA and treated with GH
The secondary objectives are to determine the metabolic effect of the combined therapy of GH plus gonadotropin agonists to that of GH alone on the dietary intake serum leptin ghrelin IGF-1 lipid and lipoprotein concentrations prior to and during treatment and to assess the quality of life between the two groups
Study population
20 prepubertal boys
Inclusion Criteria
1 Ages 10-13
2 IUGR
3 Height of at least 2 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention CDC
4 prepubertalTanner stage 1 at commencement of trail
5 Peak GH above 10ngml in at least one provocative test for GH secretion
6 Signed informed consent form
Exclusion criteria
1 Growth retardation associated with malignancy severe chronic disease genetic syndromes and endocrine disorders
2 Diabetes
3 Treatment with any medical product which may interfere with GH effects
Trail design
A prospective randomized controlled study assessing the impact of two years of combined treatment with GH and GnRHa on height of boys with severe growth failure due to SGA with height 225 SDS compared with GH alone
All subjects will be treated with NorditropinSimplex at a dosage of 100mcgkgd At onset of puberty testicular volume greater than 4 ml in consecutive examinations subjects will be randomized into either combined treatment with GH and GnRHa or GH alone
Methods
1 Urine test will be held every three months
2 X-ray photograph for bone age determination will be taken at baseline and every year after
3 Blood will be taken at baseline and every year after in order to evaluate the following parameters Lipid and lipoprotein concentrations ghrelin leptin glucose insulin and HbA1c
4 Blood will be taken on randomization visit and three months after in order to evaluated the following parameters LH FSH and Testosterone
5 Blood will be taken at baseline and every half a year after to evaluate levels of IGF-1
6 For evaluation of the growth hormone response additional blood tests will be preformed one month and three months after treatment with growth hormone
7 On every blood and urine that will be taken proteomic analysis will be held
8 Before treatment with growth hormone one year after treatment and in the end of the study quality of life questionnaire appetite questionnaire and Psychological questionnaires will be filled
The safety of growth hormone treatment will be assessed from
1 Monitoring of adverse events
2 Measurement of HbA1c
3 Measurement of hematology serum biochemistry and urinalysis laboratory variables
4 Measurement of fasting glucose and insulin concentrations
5 IGF-1
6 Physical examinations and measurements of vital signs height and body weight
7 Measurement of bone age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SGA boys 3243 | None | None | None |