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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

April 6, 2000
June 23, 2005
September 1999
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Complete list of historical versions of study NCT00005100 on ClinicalTrials.gov Archive Site
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Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
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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.

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.

Observational
Primary Purpose: Screening
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Acromegaly
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
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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
Both
20 Years to 75 Years
Yes
United States
 
NCT00005100
NCRR-M01RR00645-2525, CPMC-IRB-7590
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National Center for Research Resources (NCRR)
Columbia University
Study Chair: Pamela U. Freda Columbia University
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP