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

This study is currently recruiting participants.

Verified by Columbia University, March 2008

First Received: March 25, 2008 Last Updated: March 27, 2008 History of Changes

Sponsor:	Columbia University
Collaborators:	EMD Serono Genentech
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00646308

Purpose

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.

Condition
Growth Hormone Deficiency Pituitary Tumor

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Cancer Pituitary Tumors

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Cardiovascular risk markers, speciﬁcally lipids, CRP, IL6 and homocysteine [ Time Frame: One time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Serum samples

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
I Adult patients with GH deficiency due to a nonsecreting pituitary tumor
2 Adult patients with a nonsecreting pituitary tumor but without GH deficiency

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients with a history of nonsecreting pituitary tumor.

Criteria

Inclusion Criteria:

Adult patients with a history of a nonsecreting pituitary tumor with or without prior pituitary surgery.

Exclusion Criteria:

Current use of GH therapy or within the prior 3 months. Pituitary tumor necessitating surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646308

Contacts

Contact: John Ausiello, MD

212-305-6472

ja2395@columbia.edu

Locations

United States, New York
Columbia University Neuroendocrine Unit	Recruiting
New York, New York, United States, 10032
Contact: John Ausiello, MD 212-305-6472 ja2395@columbia.edu

Sponsors and Collaborators

Columbia University

EMD Serono

Genentech

Investigators

Principal Investigator:

Pamela U Freda, MD

Columbia University College of P & S

More Information

No publications provided

Responsible Party:	Columbia Univesrity ( Pamela U. Freda MD )
Study ID Numbers:	AAAB9681, AAAF3121
Study First Received:	March 25, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00646308 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

growth hormone deficiency, pituitary tumors

Additional relevant MeSH terms:

Pituitary Neoplasms
Dwarfism, Pituitary
Pituitary Diseases
Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Nervous System Diseases
Endocrine System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases

Supratentorial Neoplasms
Bone Diseases
Brain Neoplasms
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Hypopituitarism
Hypothalamic Neoplasms
Bone Diseases, Developmental
Nervous System Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010