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

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ClinicalTrials.gov Identifier: NCT00646308
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 28, 2008
Last Update Posted : April 26, 2011
Sponsor:
Collaborators:
EMD Serono
Genentech, Inc.
Information provided by:
Columbia University

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.

Condition or disease
Growth Hormone Deficiency Pituitary Tumor

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010


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



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

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   None Retained
Serum samples


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646308


Locations
United States, New York
Columbia University Neuroendocrine Unit
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
EMD Serono
Genentech, Inc.
Investigators
Principal Investigator: Pamela U Freda, MD Columbia University College of P & S

Responsible Party: Pamela U. Freda MD, Columbia Univesrity
ClinicalTrials.gov Identifier: NCT00646308     History of Changes
Other Study ID Numbers: AAAB9681
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by Columbia University:
growth hormone deficiency, pituitary tumors

Additional relevant MeSH terms:
Pituitary Diseases
Dwarfism, Pituitary
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism