Advertisement

Topics

Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

2014-07-23 21:46:17 | BioPortfolio

Summary

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.

Description

Patients will be treated with growth hormone in the form of Nutropin (a powder formulation that is reconstituted by the patient) or Nutropin AQ (a ready-to-use liquid) for 1 year. Both of these products are manufactured by Genentech, Inc. The starting dose will be 0.006 mg/kg given as a daily subcutaneous (SC) injection. The GH dose will be titrated 1-3 months after GH initiation to maintain blood levels of IGF-1 within the normal range for age and sex. The dose will be increased to a maximum of 0.025 mg/kg daily in adult patients <35 years and to a maximum of 0.0125 mg/kg daily in adult patients > 35 years. Pre-pubertal and adolescent patients will be dosed at 0.3 mg/kg/wk to 0.6 mg/kg/wk.

PROCEDURES:

1. To determine the effect of GH on body weight and lean body mass in CF, weight will be measured at baseline and every three months utilizing the same scale. LBM will be measured at baseline and every six months by dual emission x-ray absorptiometry (DEXA) scan.

2. To determine the effect of GH on protein breakdown and protein synthesis in CF, protein turnover studies will be performed at baseline and every 6 months utilizing the stable isotope C-leucine and mass spectrophotometric analysis.

Each subject will undergo 30-minute measurements of substrate oxidation and resting energy expenditure using hood indirect calorimetry. Substrate calculations yielding information on glucose oxidation and lipid oxidation will be determined using the methods of de Weir, and results will be correlated with measurements calculated from stable isotope infusion.

3. To determine the effect of GH on hepatic glucose production (HGP) the following study will be performed at baseline and every 6 months.

4. To quantify the portion of hepatic glucose production (HGP) derived from gluconeogenesis and glycogenolysis in the post-absorptive state. We will measure gluconeogenesis using the stable isotope 2H2O and measurement of the incorporation of 2H into the 6th and 2nd carbon of glucose, according to the method of Landau 11.

5. To determine if GH improves the nutritional status of CF patients the following nutritional status indicators will be measured at 6 month intervals: retinal binding protein, transferrin, thyroxine binding prealbumin, albumin, and lipid profile. Additionally, caloric intake and food group consumption will be analyzed by a skilled dietitian from 3-day food journals recorded every six months.

6. To determine if GH improves the clinical condition of CF patients, participants will perform pulmonary function tests, including measurement of PI and PE for estimation of respiratory muscle strength. Additionally, each subject's clinical status will be evaluated at baseline and every 3 months utilizing a modified NIH clinical status scoring system.

7. To determine if GH improves the quality of life of CF patients, participants will complete a 15-minute questionnaire to assess quality of life. This questionnaire entitled "The Cystic Fibrosis Questionnaire" has been recently developed and tested for quality. It is specific for CF patients and has been approved by the National CF Foundation.

8. All patients will have random blood glucose testing per CF Foundation guidelines. If a patient has previously undiagnosed cystic fibrosis related diabetes (CFRD) with or without fasting hyperglycemia (FH), he/she will be treated with insulin for a minimum for 3 months prior to study enrollment. Patients in all other glucose tolerance categories will be allowed to participate in the study Also, patients previously treated with insulin will be allowed to participate if HgbA1C is < 8.5%. If not, the PI will adjust insulin and maximize glycemic control for 3 months before study entry. Any patient who develops CFRD with or without FH will be continued in the study only if he/she will agree to insulin therapy. If a patient refuses insulin therapy, he/she will be discontinued from the study. Patients will continue to be screened for glucose intolerance by measuring random blood glucose and HgbA1C.

9. To further study the sustained effect of GH, all study subjects will be given the option of continuing on GH for an additional year. The same assessments above will be performed every six months for the additional year.

Statistics:

This is a pilot study of 40 subjects. Data will be assessed as mean and standard deviation. Data will then be used to compute a power analysis for a future larger study. Non-treatment data will be compared to treatment data with emphasis on the 12 and 18-month time points. Data from patients who develop CFRD while on the study, if there are any, will be analyzed separately from those who do not develop CFRD.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

Growth Hormone, Whole body Protein Turnover Study, Dual Energy X-ray Absorptiometry (DEXA)

Status

Active, not recruiting

Source

University of Texas Southwestern Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:46:17-0400

Clinical Trials [3113 Associated Clinical Trials listed on BioPortfolio]

Effects of Short-term Growth Hormone in HIV-infected Patients

The purpose of this study is to examine the short-term effects of two different doses of growth hormone on the brain's secretion of growth hormone and the body's glucose metabolism. We hy...

A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood

Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has been shown to be helpful in treating children with chronic kidney disease who fail to grow. The a...

CLA and Vitamin D on Protein Turnover

To conduct a randomized, double-blind, controlled clinical trial to determine the independent and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation o...

Hormone Treatment in Growth Hormone and Testosterone Deficient Patients

Growth hormone and gonadotropin deficiency after brain injury (TBI, ischemic stroke, SAH): the effects of hormone replacement on cognition, quality of life and body composition Randomized,...

Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

PubMed Articles [36211 Associated PubMed Articles listed on BioPortfolio]

Effects of Recombinant Human Growth Hormone in Children with Crohn's Disease on the Muscle-Bone Unit: A Preliminary Study.

There is limited information on the impact of recombinant human growth hormone (rhGH) on the muscle-bone unit in children with Crohn's disease (CD). In this pilot study, we report on the effects of rh...

Measurement duration affects the calculation of whole body protein turnover kinetics but not between-day variability.

Assessment of whole body protein turnover (WBPT) can provide fundamental information about protein kinetics which underpins the conservation of lean tissue. Reliability and methodology studies on the ...

Childhood Craniopharyngioma: A 22-Year Challenging Follow-Up in a Single Center.

Craniopharyngioma is a sellar/suprasellar benign tumor whose aggressiveness may imply in endocrine disturbances (hypothalamic obesity and hormone deficiencies). Fifty-seven patients were evaluated acc...

Isotopic turnover rates and diet-tissue discrimination depend on feeding habits of freshwater snails.

Estimates of animal diets and trophic structure using stable isotope analysis are strongly affected by diet-tissue discrimination and tissue turnover rates, yet these factors are often unknown for con...

Insulin Resistance is a Significant Determinant of Sarcopenia in Advanced Kidney Disease.

Maintenance hemodialysis (MHD) patients display significant nutritional abnormalities. Insulin is an anabolic hormone with direct effects on skeletal muscle (SM). We examined the anabolic actions of i...

Medical and Biotech [MESH] Definitions

A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.

A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.

An autosomal recessive disorder characterized by short stature, defective GROWTH HORMONE RECEPTOR, and failure to generate INSULIN-LIKE GROWTH FACTOR I by GROWTH HORMONE. Laron syndrome is not a form of primary pituitary dwarfism (GROWTH HORMONE DEFICIENCY DWARFISM) but the result of mutation of the human GHR gene on chromosome 5.

A form of dwarfism caused by complete or partial GROWTH HORMONE deficiency, resulting from either the lack of GROWTH HORMONE-RELEASING FACTOR from the HYPOTHALAMUS or from the mutations in the growth hormone gene (GH1) in the PITUITARY GLAND. It is also known as Type I pituitary dwarfism. Human hypophysial dwarf is caused by a deficiency of HUMAN GROWTH HORMONE during development.

A polypeptide that is secreted by the adenohypophysis (PITUITARY GLAND, ANTERIOR). Growth hormone, also known as somatotropin, stimulates mitosis, cell differentiation and cell growth. Species-specific growth hormones have been synthesized.

More From BioPortfolio on "Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial