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

Descriptive Information
Brief Title ^†	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
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: Adults, male or female, between the ages of 18-90. 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. 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 examine the predictive ability of these tests at a very early time after surgery. Data obtained from these tests will be compared to the data gathered at the 1 year time point. IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics, for clinical decision-making at the time of service. IGF-I and growth hormone will also be measured using other methods to attempt to investigate the variability of these hormones when different assays are used.
Detailed Description
Study Phase	N/A
Study Type ^†	Observational
Study Design ^†	Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure ^†	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.
Secondary Outcome Measure ^†	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.
Condition ^†	Acromegaly
Intervention ^†	OtherOGTT
Study Arms / Comparison Groups	Acromegaly peri- and post-op patients All patients will undergo the same procedures throughout the study.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Other
Estimated Enrollment ^†	20
Start Date ^†	June 2006
Completion Date	October 2011
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Male or Female age 18-90 Diagnosed with acromegaly from a pituitary adenoma visualized by MRI, and with elevated IGF-1 levels compared to age and gender matched control values and nadir GH response to OGTT>1mg/L Having already agreed to undergo surgical resection of their pituitary adenoma prior to study entry Must provide informed consent Exclusion Criteria: Inability to complete the protocol due to intercurrent medical or psychiatric illness Pregnant or breastfeeding Use of insulin Use of estrogen, progesterone, testosterone or thyroid hormone will be allowed as long as the dose is stable during the study
Gender	Both
Ages	18 Years - 90 Years
Accepts Healthy Volunteers	No
Contacts ^††	Lori Korsakoff, RN, 310-423-2411, korsakoffl@cshs.org Billy Gellepis, 310-423-3395, Billy.Gellepis@cshs.org
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00921609
Organization ID	8997
Secondary IDs ^††
Responsible Party	John Carmichael, MD / Attending Physician, Cedars-Sinai Medical Center
Study Sponsor ^†	Cedars-Sinai Medical Center
Collaborators ^††
Investigators ^†	Principal Investigator: John Carmichael, MD, Cedars-Sinai Medical Center
Information Provided By	Cedars-Sinai Medical Center
Verification Date	December 2010
First Received Date ^†	June 15, 2009
Last Updated Date	December 14, 2010

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.