Growth Hormone Therapy for Wasting in Cystic Fibrosis (NCT00803179) | Clinical Trial Compass
TerminatedPhase 1
Growth Hormone Therapy for Wasting in Cystic Fibrosis
Stopped: Poor enrollment, patients were lost to follow up
United States5 participantsStarted 2008-11
Plain-language 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 life. We theorize that this will occur through a multitude of factors: increased appetite, more constructive utilization of caloric intake and decreased catabolic signaling. The first aim will address changes in weight and lean body mass following the institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim will measure impact on quality of life of these individuals. Additionally, the third aim will monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim will observe changes in the subjects underlying diagnosis of CF, specifically lung function, muscle strength and inflammatory state.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy