Prinicipal Investigator: Dana S. Hardin, M.D.
Lab Manager: Mark Rice
Research Nurse: Julie Rice
Administrator: Dionn Hines
Bibliography
Projects
Growth Hormone Use in Adolescents and Adults with Cystic Fibrosis
IRB File #: 0102-035
Status: Active
Principal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: The primary endpoint of the study is to determine the effect of GH on body weight and lean body mass.
The secondary endpoints are to document improvement in: 1) whole body protein turnover, 2) hepatic glucose production, 3) bone mineral density, 4) pulmonary function status, and 5) quality of life. Adverse events, such as glucose intolerance, will be monitored.
We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of adults with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life.
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Asthma and Growth
IRB File: 0902-535
Status: Active
Priniciple Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: This is a two-step study.
- A retrospective chart review with no identifiers to a) correlate disease severity with growth and, b) correlate inhaled corticosteroid use with growth rate.
- A pilot study to compare resting energy expenditure, whole body protein turnover, levels of cytokines TNF alpha, IL1 and IL6 in 10 mild and 10 moderate short prepubertal asthmatics who have not utilized systemic steroids for at least 6 months. These endpoints will be correlated with the patient’s interval growth velocity.
We hypothesize that poor linear growth in asthma will be correlated to severity of the disease more than to corticosteroid use. We also believe that patients with severe asthma will have increased resting energy expenditure and increased protein catabolism compared to asthmatics with mild disease and that these findings will correlate with increased levels of cytokines.
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A Prospective Study Evaluating The Effects of Atazanavir on Several Metabolic Markers in HIV Patients with Dyslipidemia
IRB File #: 1103-713
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: Atazanavir, a recently approved protease inhibitor, has been associated with less dyslipidemia. The mechanisms by which this protease inhibitor (PI) may result in improved lipid profiles in unknown. It is known that many HIV patients on PI-containing highly active antiretroviral therapy (HAART) can develop diabetes and/or dyslipidemia. There are several factors that can influence the development of these comorbidities, such as hepatic insulin resistance, high hepatic glucose output, and more recently, adipocytokines. Therefore, we want to determine the influence of atazanavir on these metabolic markers.
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Effects of Growth Hormone in Chronically Ill Children
IRB File #: 0403-239
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and weight of chronically ill children who have failed to grow despite receiving adequate nutrition via gastrostomy tube or oral supplementation. We also hypothesize that this improvement in growth will be secondary to decreased cytokines. We will test our hypotheses by using a pilot study, in which we will recruit 12 chronically ill children from our clinical practice. Patients will receive treatment with GH (0.3 mg/kg/wk) for 12 months and their growth will be compared to the year before treatment. All subjects will be followed every three months for the entire 24 months.
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The Use of Nutropin Depot in HIV-Infected Adult Males
IRB File #: 0103-045
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: Replacement of growth hormone (GH) in HIV infected adults has been proven to increase lean tissue mass and clinical status. Previous studies have been conducted using daily subcutaneous injections for up to six months. The purpose of our study is to compare the metabolic effects of GH depot to daily GH, and to study short-term and long-term metabolic effects of GH in the HIV-infected adults. The major endpoint will be change in lean tissue and body composition as measured by DXA scan. The other study endpoints include: hepatic glucose production, gluconeogenesis, protein turnover, bone mineral turnover and TNF-µ levels.
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Ingested IFN-Alpha In Newly Diagnosed Type 1 Diabetes
IRB File: 1001-508
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: Our primary objective is to determine the efficacy of 5000 and 30,000 IU ingested human recombinant interferon-alpha (hrIFN-α) in prolonging the ‘honeymoon’-like period and preserving β-cell function in type 1 diabetes. Our secondary objective is to determine if 5000 or 30,000 units ingested hrIFN- α alters surrogate markers of disease.
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Growth Hormone Use in Cystic Fibrosis - A Multicenter Study
IRB File #: 0200-103
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies by our group and others have shown that human recombinant growth hormone (GH) improves height velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive results have prompted us to ask further questions regarding GH use in CF including: a) Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) Does GH use improve the patient’s quality of life?, c) Once GH is discontinued, are the positive effects sustained? We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life. We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after GH treatment is discontinued.
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Protease Inhibitors in HIV-Positive Children
IRB File #: 0801-438
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: The purpose of this project is to better understand how protease inhibitors cause diabetes and lipodystrophy in children. To complete our goal, we will perform a longitudinal prospective study of both PI naive and PI treated HIV-infected children and adolescents. We will compare these results to those from age, weight, and sex-matched non-HIV infected control children.
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Use of the Insulin Pump in CF
IRB File #: 0901-466
Status: Active
Principal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased HGP.
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A multi-center Trial of Genotropin Treatment of Children Born Small for Gestational Age (SGA): Evaluation of Predictors of/Correlates with First Year Growth Response
IRB File #: 0902-522
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: The primary objective of the study is to determine which pre-treatment variables are more predictive of responsiveness to growth hormone (as measured by change in height SDS). What within treatment correlates to growth and metabolic responsiveness are in these children with small for gestational age (SGA)/intrauterine growth retardation (IUGR) who are receiving higher than conventional doses of GH.
Secondary objectives are to study safety by recording adverse events and to evaluate whether Genotropin therapy might influence glucose tolerance.
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Growth Abnormalities in Children with Sickle Cell Disease
IRB File #: 0803-500
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: Children with sickle cell disease (SCD) are often small in height and fail to gain weight properly. Furthermore, new evidence suggests that osteoporosis is common. A few studies have described these clinical abnormalities; however, to date studies have not been done to identify the underlying metabolic changes leading to these findings. Better characterization of these metabolic changes will help us predict, and perhaps prevent short stature in these children. The specific aims for this study are:
- Measurement of the growth hormone axis, IGF-1 levels whole body protein turnover (WBPT), lean body mass (LBM) and resting energy expenditure (REE). This specific aim tests the hypothesis that children with SCD have low IGF-1 levels and low response to GH secretagogues, and that these are correlated with increased whole body protein catabolism and poor growth and are not related to high REE.
- Measurement of bone mineral content and markers of bone turnover. This specific aim tests the hypothesis that low IGF-1 and GH result in decreased bone mineral content and increased bone resorption.
We hypothesize that children with SCD have low IGF-1 levels which causes decreased protein anabolism and that decreased protein balance causes failure to attain longitudinal growth. Furthermore, decreased IGF-1 results in lower than normal osteoblast activity, which in turn leads to osteoporosis.
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Metabolic Abnormalities in Hispanic Children with Cystic Fibrosis
IRB File #: 0303-161
Status: Active
Prinicipal Investigator: Dana S. Hardin, M.D.
Study Coordinator: Julie R. Rice, R.N., B.S.N.
Description: In general, CF patients who are Hispanic have worse morbidity and mortality than Caucasian CF patients. However, the underlying mechanism(s) for this worsened status has not been elucidated. The purpose of this grant is to explore potential metabolic explanations for the worsened clinical status of Hispanic children with CF. Our central hypothesis is that hyperglycemia occurs at a younger age in Hispanics with CF and that it is principally caused by underlying insulin resistance secondary to the Hispanic heredity. We further hypothesize that insulin resistance includes hepatic insulin resistance and resistance to insulin’s anti-catabolic effect which results in excessive amino acid substrate availability for gluconeogenesis.
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