View Clinical Trial (Medical Research Study)
Growth Hormone Therapy for Wasting in Cystic Fibrosis
| City: |
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Worcester |
| State: |
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Massachusetts |
| Zip Code: |
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01655 |
| Conditions: |
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Cystic Fibrosis |
| Purpose: |
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Our hypothesis is that 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 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.
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| Study Summary: |
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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.
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| Criteria: |
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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 BMI of 22 for women and 23 for men
- Moderate or better pulmonary function (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 (>1.5X
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.
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| NCT ID: |
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NCT00803179 |
| Primary Contact: |
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Principal Investigator
Michael Stalvey, MD
Unversity of Massachusetts Medical School
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| Backup Contact: |
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N/A |
| Location Contact: |
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Worcester, Massachusetts 01655
United States
Dawn Baker, MSN
Phone: 508-334-2339
Email: dawn.baker@umassmed.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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