Status:
TERMINATED
Growth Hormone Therapy for Wasting in Cystic Fibrosis
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to stimulate weight and muscle growth which will maximize nutritional potential and improve overall quality of lif...
Detailed Description
The following is a more detailed description of the aims listed above: Specific Aim 1: Measure change in weight in adults with CF related wasting following GH therapy. 1.1) Monitor weight gained or ...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age \> 18 years
- Cystic fibrosis, diagnosed by either sweat chloride or genetic testing
- Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men
- Moderate or better pulmonary function (Forced Expiratory Volume (FEV1) \>40% of predicted).
- Agree to use an effective method of birth control to prevent pregnancy during the research study.
- Women should not nurse (breast feed) a baby while on this study because Nutropin AQ may enter breast milk and possibly harm the child.
Exclusion
- Pregnancy (positive pregnancy test) prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Pediatric patients
- Active neoplasm
- History of organ transplantation
- Prader Willi Syndrome who are severely obese or have severe respiratory impairment
- Patients with hepatic impairment resulting in abnormal coagulation studies (\>1.5 times normal reference range)
- Poorly controlled diabetes as determined by a Hemoglobin A1c greater than or equal to 9.0%.
- Individuals with electrocardiogram abnormality or cardiac pacing.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00803179
Start Date
November 1 2008
End Date
March 1 2012
Last Update
December 2 2025
Active Locations (1)
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1
Umms/Ummhc
Worcester, Massachusetts, United States, 01655