Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy (NCT03225755) | Clinical Trial Compass
CompletedNot Applicable
Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy
United States7 participantsStarted 2017-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males or females age ≥18 years with diagnosis of GH deficiency that is Adult Onset, either alone or associated with multiple pituitary hormone deficiencies and due to pituitary disease,hypothalamic disease, surgery, radiation therapy or Childhood Onset due to congenital, genetic, acquired, or idiopathic causes.
✓. Diagnosis of GH deficiency defined by: insulin tolerance test or glucagon test: peak GH response \< 3 ng/ml or 3 or more pituitary hormone deficiencies and insulin-like growth factor 1 (IGF-1) standard deviation score \< -2.0
✓. No history of diabetes mellitus and fasting blood sugar at screening visit ≤ 120 mg/dl.
✓. If patients have undergone surgical resection of a pituitary adenoma, a minimum of 12 months must have elapsed post surgery prior to enrollment and tumor will be demonstrated to be unchanged for 12 months or longer since surgery.
✓. May have a history of radiotherapy, but they must have completed their course of radiotherapy more than 3 months prior to study screening.
✓. If prior GH therapy must have not received prior GH replacement therapy in 310 the 6 months prior to screening.
✓. Stable pituitary hormone supplements (x 3 months) prior to baseline visit and normal levels of free thyroxine, testosterone in males and normal adrenal function if not on replacement therapy.
. If female, a. Not pregnant (as evidenced by a negative serum pregnancy test) or lactating and b. If of childbearing potential, agrees to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the time of screening, for the duration of the study, and for at least one month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
Exclusion criteria
✕. 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