Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 4/17/2018 |
| Start Date: | August 2007 |
| End Date: | May 2010 |
Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease
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 Crohn's) with growth
hormone (GH) for 12 months and comparing them to baseline.
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 Crohn's) with growth
hormone (GH) for 12 months and comparing them to baseline.
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 (Children's 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.
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 (Children's 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.
Inclusion Criteria:
1. Referral for continued poor growth (growth velocity less than the 25th percentile)
2. Height less than the 10th percentile
3. Weight less than the 10th percentile compared to age and gender- matched normal
values.
Exclusion Criteria:
1. Previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial
infection
2. Previous treatment with GH
3. Bone age > 17
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