Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis
Recruitment status was: Active, not recruiting
We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of patients with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life.
We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own control by obtaining medical records for 6 months to 1 year prior to study enrollment or by completing 6 months of study without GH prior to being treated for 1 yr. with GH.
Drug: Growth Hormone
Procedure: Whole body Protein Turnover Study
Procedure: Dual Energy X-ray Absorptiometry (DEXA)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 1) body weight
- 2) lean body mass.
- 1) whole body protein turnover
- 2) hepatic glucose production
- 3) bone mineral density
- 4) pulmonary function status
- 5) quality of life
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287430
|Principal Investigator:||Dana S Hardin, MD||University of Texas, Southwestern Medical Center at Dallas|