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

NCT00646308 | Terminated

• 1 other identifier: AAAB9681
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Deficiency; Pituitary Tumor

Keywords

growth hormone deficiency, pituitary tumors

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk markers, specifically lipids, CRP, IL6 and homocysteine

  One time point

Secondary Outcomes (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.

  One time point

Study Arms (2)

I

Adult patients with GH deficiency due to a nonsecreting pituitary tumor

2

Adult patients with a nonsecreting pituitary tumor but without GH deficiency

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a history of nonsecreting pituitary tumor.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• EMD Serono: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Columbia University Neuroendocrine Unit

New York, New York, 10032, United States

Location

Biospecimen

Retention: NONE RETAINED

Serum samples

MeSH Terms

Conditions

Dwarfism, Pituitary; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pamela U Freda, MD

  Columbia University College of P & S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 26, 2011

Record last verified: 2011-04

Locations

US (1)