IGF-1 Therapy in Patients With Cystic Fibrosis
Overview
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
Full Title of Study: “An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2012
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
- Drug: recombinant human IGF-1
- rhIGF-1
- Drug: Placebo
- Placebo
Arms, Groups and Cohorts
- Experimental: IGF-1
- Recombinant human IGF-1
- Placebo Comparator: Placebo
- Placebo
Clinical Trial Outcome Measures
Primary Measures
- Body weight and body composition
- Time Frame: 28 weeks
Secondary Measures
- Pulmonary function
- Time Frame: 28 weeks
- Carbohydrate tolerance
- Time Frame: 28 weeks
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Stony Brook University
- Provider of Information About this Clinical Study
- Principal Investigator: Thomas A. Wilson, Professor of Pediatrics – Stony Brook University
- Overall Official(s)
- Thomas A Wilson, MD, Principal Investigator, State Univeristy of New York, Stony Brook, NY
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