IGF-1 Therapy in Patients With Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2008 |
| End Date: | June 2012 |
An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and
composition in adults with cystic fibrosis.
28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight
and body composition in patients with cystic fibrosis.
Inclusion Criteria:
- Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis.
- Age >= 18 yr.
- Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5
Exclusion criteria:
- Hemoglobin A1C > 8.5 %
- Diabetic retinopathy
- Obstructive sleep apnea
- Respiratory failure requiring mechanical ventilation.
- Status post pulmonary transplantation.
- Concurrent or recent (within past 6 months) receipt of human growth hormone.
- History of adverse side effects to growth hormone other than carbohydrate
intolerance.
- Pregnancy or attempting pregnancy.
- Women who are breast feeding.
- Sexually active women who refuse to use or are incapable of responsibly using
reliable contraception.
- Proven non compliance with medical regimens.
- Inability or refusal to take subcutaneous injections.
- Known allergy to components in the IGF-I preparation.
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