Clinical Trial: A Study Examining the Peri- and Post-operative Dynamics of the Growth Hormone (GH) - IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection

Brief Summary:

Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a combination of these three treatments.

Subjects for this study will be recruited if they are:

  1. Adults, male or female, between the ages of 18-90.
  2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an MRI.
  3. Patients would have already agreed to have their acromegaly treated with surgery prior to study entry.

Subjects will have measurements of growth hormone using an oral glucose tolerance test (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but are being done to see if they relate more strongly to disease activity than IGF-I and growth hormone.

OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but are being done to e

Detailed Summary:
Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome: The primary objective of this study will be to determine the natural course of acromegaly treated with surgery in subjects with non-suppressed GH nadir values and normal total IGF-I values. [ Time Frame: 1 year ]

Original Primary Outcome: The primary objective of this study will be to determine the natural course of acromegaly treated with surgery in subjects with non-suppressed GH nadir values and normal total IGF-I values.

Current Secondary Outcome:

  • A second objective of the study will be to determine the reliability of GH nadir to OGTT, free IGF-I, total IGF-I, and IGF binding proteins on post-operative day 1 in predicting long-term cure outcomes in acromegaly. [ Time Frame: 1 year ]
  • A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels. [ Time Frame: 1 year ]


Original Secondary Outcome:

  • A second objective of the study will be to determine the reliability of GH nadir to OGTT, free IGF-I, total IGF-I, and IGF binding proteins on post-operative day 1 in predicting long-term cure outcomes in acromegaly.
  • A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels.


Information By: Cedars-Sinai Medical Center

Dates:
Date Received: June 15, 2009
Date Started: June 2006
Date Completion: October 2011
Last Updated: December 14, 2010
Last Verified: December 2010