Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140413
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2005-08-31
Brief Title:
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Hypotheses
1 The prevalence of endocrinopathies and growth hormone GH deficiency in particular among young children diagnosed with optic nerve hypoplasia ONH is higher than is commonly thought
2 Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes
Aims
1 Determine the prevalence and types of endocrinopathies in children diagnosed with ONH
2 Correlate endocrine outcome with radiographic ocular and developmental findings in children with ONH
3 Examine the effect of GH treatment on growth and obesity in children with ONH GH-deficiency and either subnormal or normal growth compared to children with ONH that are not GH-deficient
4 Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies
1 The prevalence of endocrinopathies and growth hormone GH deficiency in particular among young children diagnosed with optic nerve hypoplasia ONH is higher than is commonly thought
2 Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes
Aims
1 Determine the prevalence and types of endocrinopathies in children diagnosed with ONH
2 Correlate endocrine outcome with radiographic ocular and developmental findings in children with ONH
3 Examine the effect of GH treatment on growth and obesity in children with ONH GH-deficiency and either subnormal or normal growth compared to children with ONH that are not GH-deficient
4 Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies
Detailed Description:
Subjects for this study will be recruited from active and newly enrolled subjects in our larger ONH study The study duration is three years and we anticipate 38 subjects will enroll Subjects will be recruited for this study if they present with either growth deceleration or at least one subnormal result for IGF-1 or IGFBP-3
Baseline information collected includes height weight head circumference examinations by an endocrinologist and ophthalmologist endocrine laboratory testing fundus photography electrophysiology testing head MRI and a developmental assessment A glucagon stimulation test will be performed and subjects who are deemed GH-deficient and who have delayed growth will be assigned to GH treatment in line with standard clinical practice Those with normal growth but determined to be GH-deficient by a glucagon stimulation test will be randomized to treatment with GH vs control no intervention observation only
Subjects assigned or randomized to treatment with GH will be provided with GH for the duration of their participation in the study Enrolled subjects will return every four months to monitor progress Subjects will undergo a physical examination at each visit including height weight head circumference and body fat In addition subjects assigned or randomized to growth hormone will have laboratory testing of thyroid IGF-1 and IGFBP-3 hormones and fasting lipid levels
Baseline information collected includes height weight head circumference examinations by an endocrinologist and ophthalmologist endocrine laboratory testing fundus photography electrophysiology testing head MRI and a developmental assessment A glucagon stimulation test will be performed and subjects who are deemed GH-deficient and who have delayed growth will be assigned to GH treatment in line with standard clinical practice Those with normal growth but determined to be GH-deficient by a glucagon stimulation test will be randomized to treatment with GH vs control no intervention observation only
Subjects assigned or randomized to treatment with GH will be provided with GH for the duration of their participation in the study Enrolled subjects will return every four months to monitor progress Subjects will undergo a physical examination at each visit including height weight head circumference and body fat In addition subjects assigned or randomized to growth hormone will have laboratory testing of thyroid IGF-1 and IGFBP-3 hormones and fasting lipid levels
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