Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

Descriptive Information
Brief Title ^†	Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
Official Title ^†
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 Phase	N/A
Study Type ^†	Observational
Study Design ^†	Primary Purpose: Screening
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Acromegaly
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†
Estimated Enrollment ^†	165
Start Date ^†	September 1999
Completion Date
Primary Completion Date
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	Both
Ages	20 Years - 75 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts ^††	, , , ,
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00005100
Organization ID	NCRR-M01RR00645-2525
Secondary IDs ^††	CPMC-IRB-7590
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	Columbia University
Investigators ^†	Study Chair: Pamela U. Freda, Columbia University
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	December 2003
First Received Date ^†	April 6, 2000
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.