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Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Columbia University
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00005100
First received: April 6, 2000
Last updated: June 23, 2005
Last verified: December 2003
  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

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Columbia University
Investigators
Study Chair: Pamela U. Freda Columbia University
  More Information

No publications provided

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

Keywords provided by National Center for Research Resources (NCRR):
acromegaly
endocrine disorders
rare disease

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 19, 2014