NCT03225755

Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Growth hormone	Patients will receive growth hormone replacement therapy as per standard clinical care during this study.

Timeline

• Start date: 2017-08-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2017-07-21
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study