Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly
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|ClinicalTrials.gov Identifier: NCT00921609|
Recruitment Status : Recruiting
First Posted : June 16, 2009
Last Update Posted : July 29, 2020
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.
|Condition or disease||Intervention/treatment|
|Acromegaly||Diagnostic Test: Oral glucose tolerance test|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
All patients will undergo oral glucose tolerance test at postoperative day 1, 6 weeks, 3 months, and 1 year
Diagnostic Test: Oral glucose tolerance test
An oral glucose tolerance test is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
- Correlation of normalization of Growth hormone postoperatively with 1 year remission rates [ Time Frame: 1 year ]The primary endpoint will be to assess if a higher proportion of subjects in group 2b (low normal IGF-1 and elevated GH) normalize their GH nadir responses to OGTT than subjects in group 2a (high normal IGF-1 and elevated GH) at either the three month time point or 12 month time point.
- Predictor of remission [ Time Frame: 1 year ]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.
- Assay variability of IGF-1 and GH [ Time Frame: 1 year ]A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921609
|Contact: Vivian Hwe, BSfirstname.lastname@example.org|
|United States, California|
|Cedars-Sinai Medical Center, Pituitary Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Odelia Cooper, MD||Cedars-Sinai Medical Center|