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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