Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Relative gene expression values of CD68 gene
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Have other conditions that may result in abnormal GH and/or IGF-I concentrations (e.g., severe hepatic disease, severe renal disease, malnutrition, treatment with levodopa).
- •Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≥ 2 x upper limit of normal or clinically significant hepatic disease or renal impairment defined as creatinine > 1.5x upper normal.
- •Have a pituitary adenoma with a distance to the optic chiasm of 5 mm or less, confirmed by a recent MRI scan (within two months prior to the screening visit).
- •Pituitary tumor growth within the 12 months prior to study entry.
- •GH therapy within 6 months of screening.
- •Diabetes mellitus.
- •History of acromegaly.
- •History of active Cushing's disease within 24 months of screening
- •Visual field defects or other neurological symptoms due to current tumor mass compression.
- •Have known or suspected drug or alcohol abuse.
- •Have received an investigational medication within four weeks prior to Screening or is scheduled to receive any investigational medication during the study.
- •Do not have the ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol.
- •Have other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •History of a malignancy other than squamous or basal cell skin carcinoma that has been excised or intracranial malignant tumors or leukemia within 5 years of screening.
- •Patients who have a known hypersensitivity to GH therapy
- •Use of weight 349 loss medications
- •Females who plan to change estrogen therapy during the trial
- •Patients who have received supraphysiologic doses of glucocorticoids within the past 6 months (except for peri-operative (< 3 days duration) of dexamethasone), or who are currently receiving any chemotherapeutic agents.
- •Patients who have received other investigational drugs administered or received within 30 days of study entry
研究组 & 干预措施
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.
干预措施: Growth hormone (Drug)
结局指标
主要结局
Relative gene expression values of CD68 gene
时间窗: Baseline to 12 months of GH therapy
Relative gene expression values of cluster of differentiation (CD68) gene in adipose tissue
次要结局
- Intra-hepatic lipid level(Baseline to 12 months of GH therapy)
- Homocysteine level(Baseline to 12 months of GH therapy)
- Resting metabolic rate(Baseline to 12 months of GH therapy)
- Interleukin 6 (IL-6) level(Baseline to 12 months of GH therapy)
- Relative gene expression values of MCP1 gene(Baseline to 12 months of GH therapy)
- Relative gene expression values of CD11c gene(Baseline to 12 months of GH therapy)
- C-reactive protein level(Baseline to 12 months of GH therapy)
- Relative gene expression IL6 gene(Baseline to 12 months of GH therapy)
- Visceral Adipose Tissue (VAT) mass(Baseline to 12 months of GH therapy)
- TNFα level(Baseline to 12 months of GH therapy)
研究者
Pamela U. Freda
Professor of Medicine at CUMC
Columbia University