Recruiting

Surgical TreatmentMeasurement of Outcome of Surgical Treatment in Patients With Acromegaly

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00005100

Conditions

Acromegaly

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT00005100

Start date

Sep, 1999

Status verified date

Dec, 2003

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

165 participants

Interventions and Outcome Measures

Central Contacts and Locations

Locations

Columbia University College of Physicians and Surgeons

Recruiting

New York, New York, United States, 10032

Contacts

Pamela U. Freda

212-305-3725

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

acromegaly
endocrine disorders
rare disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.