Effects of Growth Hormone in Chronically Ill Children
| Status: | Withdrawn |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis, HIV / AIDS, Neurology, Gastrointestinal, Crohns Disease, Metabolic |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Neurology, Pharmacology / Toxicology, Rheumatology |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 12/16/2018 |
| Start Date: | February 3, 2006 |
| End Date: | February 3, 2006 |
The specific aims for this study are -
1. To determine the effect of GH on height, height velocity, body weight and lean body
mass. This specific aim tests the hypothesis that GH significantly improves height,
height velocity, weight, weight velocity and lean body mass in chronically ill children
who have grown poorly despite adequate nutritional rehabilitation.
2. To determine the effect of GH on whole body protein turnover (WBPT), IGF-1 levels and on
cytokines. 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 GH treatment.
3. Evaluation of bone mineral density and bone turnover. 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.
We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and
weight of chronically ill children who have failed to grow despite receiving adequate
nutrition via gastrostomy tube or oral supplementation.
1. To determine the effect of GH on height, height velocity, body weight and lean body
mass. This specific aim tests the hypothesis that GH significantly improves height,
height velocity, weight, weight velocity and lean body mass in chronically ill children
who have grown poorly despite adequate nutritional rehabilitation.
2. To determine the effect of GH on whole body protein turnover (WBPT), IGF-1 levels and on
cytokines. 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 GH treatment.
3. Evaluation of bone mineral density and bone turnover. 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.
We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and
weight of chronically ill children who have failed to grow despite receiving adequate
nutrition via gastrostomy tube or oral supplementation.
We will test our hypotheses by using a pilot study, in which we will recruit 18 chronically
ill children from our clinical practice. We will obtain medical records for each patient 12
months prior to starting the study. Those patients without pre-study medical records will be
studied for 12 months prior to starting GH. If we can obtain 6 months of prior medical
records, then the patients will be studied for 6 months before starting GH. Anything less
than 6 months will be studied for the full 12 months prior to starting GH. Patients will
receive treatment with GH (0.3 mg/kg/wk) for 12 months and their growth will be compared to
the year before treatment. All subjects will be followed every three months for the entire
study. We will measure height and weight using a standardized stadiometer and scale,
respectively, every three months during the study. From these measurements we will calculate
height and weight velocity and height and weight Z score. Lean body mass (LBM) will be
measured by DEXA every six months. Utilizing the stable isotope 1-[13C] leucine, we will
measure whole body protein turnover (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. We will evaluate GH effects
on these levels.
ill children from our clinical practice. We will obtain medical records for each patient 12
months prior to starting the study. Those patients without pre-study medical records will be
studied for 12 months prior to starting GH. If we can obtain 6 months of prior medical
records, then the patients will be studied for 6 months before starting GH. Anything less
than 6 months will be studied for the full 12 months prior to starting GH. Patients will
receive treatment with GH (0.3 mg/kg/wk) for 12 months and their growth will be compared to
the year before treatment. All subjects will be followed every three months for the entire
study. We will measure height and weight using a standardized stadiometer and scale,
respectively, every three months during the study. From these measurements we will calculate
height and weight velocity and height and weight Z score. Lean body mass (LBM) will be
measured by DEXA every six months. Utilizing the stable isotope 1-[13C] leucine, we will
measure whole body protein turnover (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. We will evaluate GH effects
on these levels.
Inclusion Criteria:
- Ages 3-17 years
- Tanner stages 1-3
- Each child must have received adequate nutritional therapy supplied by aggressive oral
supplementation, gastrostomy tube, or TPN for at least 1 year prior to enrollment.
- All children will have been referred for continued poor growth and will be less than
the 10th percentile for height compared to age and gender normal values.
- low IGF-1 level at the time of enrollment (measured in the Endocrine clinic).
- Chronic illness to be included are Hurler Syndrome (MPS-1) with short stature and
muscle wasting, cerebral palsy with muscle wasting, juvenile rheumatoid arthritis with
muscle wasting and short stature, Crohn's disease and HIV infection.
Exclusion Criteria:
- previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial
infection.
- substantial change in steroid dosing, or having a formerly steroid negative patient
start long-term-steroids (anticipated use greater that 7 days
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