Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511329
Status:
TERMINATED
Last Update Posted:
2018-04-12
First Post:
2007-08-02
Brief Title:
Growth Hormone in Children With Juvenile Rheumatoid Arthritis JRA and With Crohns Disease
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohns Disease
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that the anabolic effects of Genotropin somatropin will improve the height and weight of children with inflammatory based chronic illness who have failed to grow despite receiving adequate nutrition The investigators will test the hypothesis by treating 32 chronically ill children 16 JRA and 16 Crohns with growth hormone GH for 12 months and comparing them to baseline
Detailed Description:
1 To determine the effect of GenotropinTM on height height velocity body weight and lean body mass Growth records from previous years will be assessed to determine growth velocity and weight gain We will measure height and weight during the study using a standardized stadiometer and scale These parameters will be converted to Z scores GenenCalcTM Genentech Lean body mass LBM will be measured by DXA every six months This specific aim tests the hypothesis that GH significantly improves height height velocity weight weight velocity and LBM in chronically ill children who have grown poorly despite adequate nutritional rehabilitation
2 To determine the effect of GenotropinTM on whole body protein turnover WBPT IGF-1 levels and cytokines Utilizing the stable isotope 1-13C leucine we will measure WBPT Measurements of WBPT will be correlated with LBM and changes in height and weight velocity This data will be compared to that from age matched normal children archival data maintained by the PI We will measure IGF-1 and the cytokines TNF-α IL-6 and IL-10 at baseline and very six months These measures will be correlated with height and weight velocity and IGF-1 levels Cytokine levels will also be correlated with protein catabolism This specific aim tests the hypothesis that chronically ill children have increased catabolism caused by high levels of circulating cytokines and low levels of IGF-1 and that these abnormalities improve with GenotropinTM
3 Evaluation of bone mineral content BMC and bone turnover At baseline and every six months we will measure BMC of the whole body hip and spine using DXA Results will be compared to those from age-matched normal children whose results are archived in the body composition laboratory of Dr Ken Ellis Childrens Nutrition Research Center Houston At baseline and every six months we will also measure bone mineral turnover markers including osteocalcin bone specific alkaline phosphatase activity and deoxypyridinoline All findings will be related to cytokine levels and to use of glucocorticoids This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine levels
2 To determine the effect of GenotropinTM on whole body protein turnover WBPT IGF-1 levels and cytokines Utilizing the stable isotope 1-13C leucine we will measure WBPT Measurements of WBPT will be correlated with LBM and changes in height and weight velocity This data will be compared to that from age matched normal children archival data maintained by the PI We will measure IGF-1 and the cytokines TNF-α IL-6 and IL-10 at baseline and very six months These measures will be correlated with height and weight velocity and IGF-1 levels Cytokine levels will also be correlated with protein catabolism This specific aim tests the hypothesis that chronically ill children have increased catabolism caused by high levels of circulating cytokines and low levels of IGF-1 and that these abnormalities improve with GenotropinTM
3 Evaluation of bone mineral content BMC and bone turnover At baseline and every six months we will measure BMC of the whole body hip and spine using DXA Results will be compared to those from age-matched normal children whose results are archived in the body composition laboratory of Dr Ken Ellis Childrens Nutrition Research Center Houston At baseline and every six months we will also measure bone mineral turnover markers including osteocalcin bone specific alkaline phosphatase activity and deoxypyridinoline All findings will be related to cytokine levels and to use of glucocorticoids This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine 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