Inter-Assay Growth Hormone and IGF-I Variability

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Brief Title

Inter-Assay Growth Hormone and IGF-I Variability

Official Title

Inter-Assay Growth Hormone and IGF-I Variability

Brief Summary

      The purpose of this study is to demonstrate the degree of variability in commercially
      available assays for Growth Hormone measurement in the context of clinical decision making
      for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I
      inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing
      and Oral Glucose Tolerance Testing.

Detailed Description

      This research will explore the variability of GH and IGF-1 measurements by commercially
      available tests. The hypothesis is that the variability in GH and IGF-1 measurement will be
      sizable enough that different conclusions would be drawn in patient case decision making in
      the diagnosis and management of GH deficiency and acromegaly.

      In order to correctly diagnose disorders of growth hormone secretion, either deficiency or
      excess, it is necessary to have the accurate measurement of GH (growth hormone) serum and
      Insulin-like growth factor (IGF-1).

      For this study, subjects will be asked to give the Investigators additional blood during
      either an OGTT (a test for acromegaly) or a growth hormone stimulation test (GHRH-arginine
      stimulation). Ordinarily, blood would be measured at the beginning and end of the OGTT, and
      for the GHRH-arginine it would be measured one half hour before the test and then every half
      hour for 2 hours.

      For this study, subjects will provide us with additional blood at the times when blood is
      drawn for the clinically-indicated tests. No additional needle sticks will be necessary and
      taking the additional blood will not interfere with the clinical test.

      The test we will be doing with the additional blood will be identical to the tests we
      ordinarily do, but will be done by a different lab. We are testing to see if these results
      would be the same as our usual lab.

      The study population will include 1) subjects with pituitary disease undergoing testing for
      GH deficiency (GHRH arginine stimulation test), 2) subjects with suspicion of acromegaly
      undergoing the oral glucose tolerance test (oGTT), and 3) normal controls undergoing both the
      GHRH Arginine test and the oGTT. Patients from all groups will have their blood drawn for the
      measurement of IGF-1. The serum from each test will be aliquoted and sent to the designated

      For subject groups 1 and 2, this study poses no more than minimal risk, as it involves
      procedures that do not go beyond clinical care. For healthy controls, we know that
      participants will be asked to undergo testing that would not normally be required, and
      therefore feel that the study poses more than minimal risk.

      For the primary endpoint research samples will be compared to samples sent to the usual
      clinical lab, and diagnoses made based on research samples will be compared to clinical

      For secondary endpoints, each result from a commercially available assay will be correlated
      to another corresponding method of analysis of the same hormone from the same time point by
      using the Bland-Altman analysis wherein the difference between two methods is compared to the
      mean of the two methods. Each sample will be compared to the sample used for clinical

      Information from the medical records will be obtained and correlated with the lab test

Study Type





* 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


Start Date

November 2007

Completion Date

January 2011

Eligibility Criteria

        Inclusion Criteria:

          1. Male or Female age 18+

          2. Clinical indication for testing GH response to secretagogue testing to evaluate for
             GHD OR clinical indication for testing for GH response to oral glucose load (75grams
             of glucose) to evaluate for Acromegaly either for diagnosis OR normal volunteer for
             control group.

               -  Normal volunteers will be screened for evidence of pituitary endocrine
                  dysfunction prior to Oral Glucose Tolerance Testing (OGTT) and Growth Hormone
                  Releasing Hormone - Arginine Testing (GHRH-ARG).

          3. Able to provide informed consent

        Exclusion Criteria:

          1. Subjects taking GH

          2. Pregnant or breast feeding




18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


John Carmichael, MD, , 

Administrative Informations



Organization ID


Study Sponsor

Cedars-Sinai Medical Center

Study Sponsor

John Carmichael, MD, Principal Investigator, Cedars-Sinai Medical Center

Verification Date

September 2008