Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

NCT00005100 | Unknown

• 2 other identifiers: NCRR-M01RR00645-2525CPMC-IRB-7590
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric assay (IRMA) in patients with acromegaly and normal volunteers. II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts. III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as assessed by sensitive IRMA. IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk for progression to active disease.

Conditions

Acromegaly

Keywords

acromegaly; endocrine disorders; rare disease

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of acromegaly and treated with transsphenoidal surgery Biochemically and histologically confirmed growth hormone secreting tumor OR Healthy volunteers --Prior/Concurrent Therapy-- Surgery: * See Disease Characteristics * Greater than 6 months since prior surgery Other: At least 1 month since prior bromocriptine or octreotide --Patient Characteristics-- Performance status: Ambulatory Hepatic: No active hepatic disease Renal: No active renal disease Other: * No diabetes mellitus * No glucose intolerance * Hypopituitarism allowed if on stable doses of replacement therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Columbia University: collaborator

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Acromegaly; Endocrine System Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela U. Freda

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: April 7, 2000
• Study Start: September 1, 1999
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)