Cystic Fibrosis
Conditions
Keywords
Body weight, Body composition, Pulmonary function, Carbohydrate tolerance
Brief summary
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
Detailed description
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.
Interventions
rhIGF-1
DRUGPlacebo
Placebo
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight and body composition | 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function | 28 weeks |
| Carbohydrate tolerance | 28 weeks |
Countries
United States
Outcome results
None listed