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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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In order to examine the effect of GH on adipose tissue inflammation, this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will also obtain serum samples before and after treatment for adipokines, inflammatory markers and examine macrophages in circulation with regard to their inflammatory state. The investigators will also obtain adipose tissue biopsies from healthy subjects matched to the growth hormone deficiency (GHD) subjects. Adipose tissue specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene expression, and adipose tissue macrophage number.
The growth hormone (GH) axis has important influences on adipose tissue. GH may have a novel effect to reduce macrophage yet increase adipocyte inflammation in adipose tissue along with reducing adipose tissue mass. Disordered adipose tissue metabolism may dysregulate adipokine secretion, which could contribute to metabolic abnormalities in GH deficiency. Adipokines, peptides expressed and secreted by adipose tissue, exert important local adipose tissue and systemic metabolic effects. This study will combine direct assessment of adipose tissue with assessment of body composition. Adult GHD can be associated with central adiposity, insulin resistance, dyslipidemia and increased cardiovascular (CV) risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with growth hormone deficiency | 12 subjects with GH deficiency, adult or childhood onset, and not currently on GH therapy will be studied. Subjects enrolled will be those planning GH therapy and beginning this therapy as part of their routine clinical care. Subjects will be 50% female and all subjects will be on 3 months of stable hormone replacements prior to testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone | Drug | Patients will receive growth hormone replacement therapy as per standard clinical care during this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative gene expression values of CD68 gene | Relative gene expression values of cluster of differentiation (CD68) gene in adipose tissue | Baseline to 12 months of GH therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Relative gene expression IL6 gene | Relative gene expression interleukin 6 (IL6) gene in adipose tissue | Baseline to 12 months of GH therapy |
| Relative gene expression values of MCP1 gene | Relative gene expression values of monocyte chemoattractant protein-1 (MCP1) gene in adipose tissue |
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Inclusion criteria:
Exclusion Criteria:
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Potential subjects include all those who present to our Neuroendocrine Unit for therapy of GH deficiency or who are followed in our unit and have GH deficiency and are planning to initiate a therapy. Subjects will be those with central adiposity. We expect are study group to be approximately half women and reflect the ethnic mix of our study populations of our other pituitary tumor studies, which is primarily drawn from the New York Metropolitan area.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U. Freda, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroendocrine Unit and Pituitary Center, Columbia University | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Baseline to 12 months of GH therapy |
| Relative gene expression values of CD11c gene | Relative gene expression values of CD11c gene in adipose tissue | Baseline to 12 months of GH therapy |
| Visceral Adipose Tissue (VAT) mass | Visceral Adipose Tissue (VAT) mass as measured by magnetic resonance imaging of abdomen | Baseline to 12 months of GH therapy |
| Intra-hepatic lipid level | Intra-hepatic lipid level measured by magnetic resonance imaging of liver | Baseline to 12 months of GH therapy |
| Resting metabolic rate | Resting metabolic rate | Baseline to 12 months of GH therapy |
| Interleukin 6 (IL-6) level | Plasma level of interleukin 6 (IL-6) | Baseline to 12 months of GH therapy |
| TNFα level | Plasma level of tumor necrosis factor alpha (TNFα) | Baseline to 12 months of GH therapy |
| C-reactive protein level | Plasma level of c-reactive protein (CRP) | Baseline to 12 months of GH therapy |
| Homocysteine level | Plasma level of homocysteine | Baseline to 12 months of GH therapy |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |