Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Columbia University
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00005100

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.

Condition
Acromegaly

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	165
Study Start Date:	September 1999

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of acromegaly and treated with transsphenoidal surgery

Biochemically and histologically confirmed growth hormone secreting tumor

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005100

Locations

United States, New York
Columbia University College of Physicians and Surgeons	Recruiting
New York, New York, United States, 10032
Contact: Pamela U. Freda 212-305-3725

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Columbia University

Investigators

Study Chair:

Pamela U. Freda

Columbia University

More Information

Study ID Numbers:	NCRR-M01RR00645-2525, CPMC-IRB-7590
Study First Received:	April 6, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005100
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

acromegaly
endocrine disorders
rare disease

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Musculoskeletal Diseases
Rare Diseases
Central Nervous System Diseases

Endocrine System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009