Clinical Trial: Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas

Brief Summary: The purpose of this study is to determine if patients with a history of nonsecreting pituitary adenomas with untreated GH deficient patients have profiles consistent with increased cardiovascular risk compared to patients without GH deficiency who have undergone similar surgery.

Detailed Summary:

PROJECT TITLE: Assessment of Cardiovascular Risk in Patients with Growth Hormone Deficiency Following Transsphenoidal Surgery for Nonsecreting Pituitary Adenomas.

BACKGROUND Recently, an awareness of the risks of hypopituitarism in adults has been raised by epidemiological studies demonstrating its association with increased mortality, likely from cardiovascular (CV) causes. In particular, untreated growth hormone deficiency has been implicated as a possible cause of this increased mortality. A 2004 clinical review of growth hormone deficiency in adults highlights the plausibility of this argument by citing studies potentially linking GHD to the following: elevated CRP, LDL and coagulation factor levels, increased abdominal obesity, increased insulin resistance, increased prevalence of structural and functional heart disease and increased rates of endothelial cell and large artery dysfunction. Furthermore, therapy for GH deficiency has been shown to lower total and LDL cholesterol and reduce visceral fat mass, reduce signs of early atherosclerosis and perhaps decrease overall risk of myocardial infarction. While these studies suggest that GHD is an important cardiovascular risk factor, we believe the data are imperfect since some of the studies chose comparison groups too dissimilar (allowing for the possibility of unrecognized confounding). Previous studies have assessed cardiovascular risk in patients with hypopituitarism in comparison to the general population or much younger GH replaced subjects or GHD patients before and after GH therapy. In contrast, we plan to compare cardiovascular risk among adult patients rendered growth hormone deficient following surgery for a non secreting pituitary adenoma versus patients who have undergone the same surgery but who remain growth hormone sufficient. We plan to test for growth hormone deficiency using the Arginine/GHRH stimula
Sponsor: Columbia University

Current Primary Outcome: Cardiovascular risk markers, specifically lipids, CRP, IL6 and homocysteine [ Time Frame: One time point ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Total body fat, trunk fat and lean body mass by DEXA, insulin sensitivity, flow mediated dilatation and endothelial cell biopsy, carotid IMT, intramyocellular and intrahepatic lipid content. [ Time Frame: One time point ]

Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: March 25, 2008
Date Started: March 2008
Date Completion:
Last Updated: April 22, 2011
Last Verified: April 2011