Brief Title
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
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.
Detailed Description
PROTOCOL OUTLINE: Blood samples are collected and assessed for growth hormone and IGF-I by polyclonal radioimmunoassay (RIA) and immunoradiometric assay (IRMA). Growth hormone is measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. Serum glucose is measured at baseline and at 2 hours post dextrose administration by the glucose hexokinase method. Clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne. Exams and tests may be repeated every 6 months for 2 years.
Study Type
Observational
Condition
Acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
165
Start Date
September 1999
Eligibility Criteria
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
Gender
All
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Pamela U. Freda, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00005100
Organization ID
NCRR-M01RR00645-2525
Secondary IDs
CPMC-IRB-7590
Study Sponsor
National Center for Research Resources (NCRR)
Collaborators
Columbia University
Study Sponsor
Pamela U. Freda, Study Chair, Columbia University
Verification Date
December 2003