Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

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 Type

Observational

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

165

Start Date

September 1999

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

All

Ages

20 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pamela U. Freda, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00005100

Organization ID

NCRR-M01RR00645-2525

Secondary IDs

CPMC-IRB-7590

Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 Columbia University

Study Sponsor

Pamela U. Freda, Study Chair, Columbia University

Verification Date

December 2003