Trials / Completed
CompletedNCT03500913
Adipose Tissue and Serum Inflammation in GH Deficiency
Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- Columbia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
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
- 2019-05-19
- Primary completion
- 2020-02-12
- Completion
- 2020-02-20
- First posted
- 2018-04-18
- Last updated
- 2025-05-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03500913. Inclusion in this directory is not an endorsement.