Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00005100


Primary Contact:

Study Chair
Pamela U. Freda
Columbia University


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States

Pamela U. Freda
Phone: 212-305-3725

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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