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

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborators:
EMD Serono
Genentech
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00646308
First received: March 25, 2008
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  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: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas

Resource links provided by NLM:

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

Serum samples


Estimated Enrollment: 60
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: January 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

Locations
United States, New York
Columbia University Neuroendocrine Unit
New York, New York, United States, 10032
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: Pamela U. Freda MD, Columbia Univesrity
ClinicalTrials.gov Identifier: NCT00646308     History of Changes
Other Study ID Numbers: AAAB9681
Study First Received: March 25, 2008
Last Updated: April 22, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013