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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK110771-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will examine adipose tissue inflammation and adipokine expression and serum markers of inflammation and adipokine levels in patients with growth hormone (GH) deficiency before and after treatment.
The GH axis has important influences on adipose tissue. Preliminary data from the investigators' study in acromegaly, a state of GH excess, suggests that GH reduces adipose tissue (AT) mass and serum inflammation. However, GH seems to reduce macrophage markers in adipose tissue yet increase adipocyte inflammation. This novel dissociation of macrophage and adipocyte inflammation is hypothesized to be due to GH. In order to examine this hypothesis further this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will obtain subcutaneous adipose tissue by biopsy in patients with active GH deficiency planning to undergo therapy for GH deficiency. Concurrently serum samples will be taken for analysis of levels of inflammatory markers and adipokines. After treatment for 12 months with a normal levels of Insulin-like growth factor 1 (IGF-1), a marker of GH deficiency, patients will have a repeat adipose tissue biopsy. Adipose tissue parameters will be analyzed in each specimen and then compared to each patient over time as well as to body mass index (BMI)-matched control subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with growth hormone deficiency | Subjects who present to the neuroendocrine unit at Columbia University Irving Medical Center (CUIMC) for therapy of GH deficiency or who are followed in the unit and have active GH deficiency and are planning to initiate a therapy. |
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| Control group | Healthy subjects matched to the GH deficiency subjects for age (+/- 5 years), gender and total fat mass (+/- 4%). |
| 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 |
|---|---|---|
| Visceral Adipose Tissue (VAT) mass | Visceral adipose tissue mass as measured by tota body magnetic resonance imaging | Baseline to 12 months of GH therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-hepatic lipid level | Intra-hepatic lipid level measured by magnetic resonance imaging of liver | Baseline to 12 months of GH therapy |
| Skeletal Muscle Mass | Skeletal muscle mass measured by total body magnetic resonance imaging |
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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 Irving Medical Center | 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 |
| Total body fat | Total body fat as measured by dual x-ray absorptiometry | Baseline to 12 months of GH therapy |
| Resting metabolic rate | Resting metabolic rate | Baseline to 12 months of GH therapy |
| Relative gene expression of CD68 gene | Relative gene expression values of Cluster of Differentiation 68 (CD68) gene expression 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 (MCP-1) gene in adipose tissue | Baseline to 12 months of GH therapy |
| Relative gene expression IL6 gene | Relative gene expression Interleukin 6 (IL6) gene in adipose tissue | Baseline to after 12 months of treatment for GH deficiency |
| Relative gene expression values of CD11c gene | Relative gene expression values of CD11c gene in adipose tissue | 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 |
| CRP 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 |