A Phase 1 interventional study of Nutropin AQ in Cystic Fibrosis, sponsored by University of Massachusetts, Worcester. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by University of Massachusetts, Worcester · Phase 1, Interventional, and Treatment
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.
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 loss from baseline. 1.2) Assess changes in fat free mass from baseline by bioelectrical impedence analysis.
Specific Aim 2: Evaluate overall quality of life (QOL) in adults with CF related wasting treated with GH therapy.
2.1) Perform CF disease-specific and general QOL analysis via CF QOL questionnaires.
2.2) Monitor compliance with therapy via subject report.
Specific Aim 3: Monitor impact of GH therapy in relation to CF related diabetes onset or control.
3.1) Measure impact on insulin sensitivity in non-diabetes subjects 3.2) Observe change in exogenous insulin requirements and glycemic control in subjects with diabetes.
Specific Aim 4: Quantify impact of anabolic therapy on manifestations of underlying diagnosis associated with CF.
4.1) Observe changes in lung function from baseline during GH therapy. 4.2) Determine changes in overall muscle strength via hand grip and six minute walk.
4.3) Evaluate changes in serum markers.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 5 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Nutropin Aqueous (AQ): Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
Drug: Nutropin AQ
Based on recommendations from the 2007 GH Deficiency Consensus Workshop on adult GH deficiency, the recommended initiation of treatment for adult males is 0.2mg/d and for women 0.4mg/d, with a titration upwards based on insulin-like growth factor (IGF-1) (product of GH stimulation at target tissues) levels and patient response. IGF-1 will be monitored at the 3,4,5 and 11 month intervals. For subjects under the age of 25 with an open epiphysis of the hand and/or wrist we will treat with the dose of 0.3mg/kg/week. Subjects will be on growth hormone for 8 months with a baseline visit prior to initiation of therapy and a 3 month follow-up visit after stopping therapy.
Also known as: Growth Hormone (GH)
Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy
Time frame: 14 months
Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy
Time frame: 14 months
| Milestone | Growth Hormone Therapy |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
No measurements were reported for this outcome.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Growth Hormone Therapy | — | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Growth Hormone Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Growth Hormone Therapy |
|---|---|
| Female | 0 |
| Male | 5 |
| Region of Enrollment(participants) | Growth Hormone Therapy |
|---|---|
| United States | 5 |
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester