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PI moved from the institution. Study did not enroll any patients.
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The purpose of this study is to test the effect of long-acting somatostatin analog medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in comparison to healthy controls who are not receiving the medication in order to see whether or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of the medication and the underlying disease state can be analyzed.
Subjects will be informed of the study and after providing written informed consent, subjects will be asked to undergo a 2-hour oral glucose tolerance test (ingestion of 75g glucose with subsequent timed assessment of growth hormone, glucose, insulin and related binding proteins.) Baseline assessment of hormones that may contribute to the results will be drawn, prior to performing the test. Patients will be asked to complete one visit total to participate in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acromegaly | Patients carrying the diagnosis of acromegaly who are on long-acting somatostatin for at least 3 months prior to study enrollment. |
| |
| Carcinoid Syndrome | Patients carrying a diagnosis of carcinoid syndrome who are taking long-acting somatostatin for at least 3 months prior to study enrollment. |
| |
| Healthy Controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Other | An OGTT 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Growth hormone response to OGTT | assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Enrollment will include subjects diagnosed with acromegaly or carcinoid syndrome who are taking long-acting somatostatin analogs for at least three months prior to study enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Odelia Cooper | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center, Pituitary Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5006772 | Background | Earll JM, Sparks LL, Forsham PH. Glucose suppression of serum growth hormone in the diagnosis of acromegaly. JAMA. 1967 Aug 21;201(8):628-30. No abstract available. | |
| 20410227 | Background | Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S; Acromegaly Consensus Group. A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab. 2010 Jul;95(7):3141-8. doi: 10.1210/jc.2009-2670. Epub 2010 Apr 21. |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Blood will be drawn (approx. 64cc) to gather baseline hormone and metabolic panels. Blood will again be collected (approx. 36cc) during the Oral Glucose Tolerance Test.
| 12601629 | Background | Vierhapper H, Heinze G, Gessl A, Exner M, Bieglmayr C. Use of the oral glucose tolerance test to define remission in acromegaly. Metabolism. 2003 Feb;52(2):181-5. doi: 10.1053/meta.2003.50036. |
| 19033371 | Background | Carmichael JD, Bonert VS, Mirocha JM, Melmed S. The utility of oral glucose tolerance testing for diagnosis and assessment of treatment outcomes in 166 patients with acromegaly. J Clin Endocrinol Metab. 2009 Feb;94(2):523-7. doi: 10.1210/jc.2008-1371. Epub 2008 Nov 25. |
| 20813787 | Background | Rubeck KZ, Madsen M, Andreasen CM, Fisker S, Frystyk J, Jorgensen JO. Conventional and novel biomarkers of treatment outcome in patients with acromegaly: discordant results after somatostatin analog treatment compared with surgery. Eur J Endocrinol. 2010 Nov;163(5):717-26. doi: 10.1530/EJE-10-0640. Epub 2010 Sep 2. |
| 13975314 | Background | ROTH J, GLICK SM, YALOW RS, BERSON SA. Secretion of human growth hormone: physiologic and experimental modification. Metabolism. 1963 Jul;12:577-9. No abstract available. |
| 18171702 | Background | Arafat AM, Mohlig M, Weickert MO, Perschel FH, Purschwitz J, Spranger J, Strasburger CJ, Schofl C, Pfeiffer AF. Growth hormone response during oral glucose tolerance test: the impact of assay method on the estimation of reference values in patients with acromegaly and in healthy controls, and the role of gender, age, and body mass index. J Clin Endocrinol Metab. 2008 Apr;93(4):1254-62. doi: 10.1210/jc.2007-2084. Epub 2008 Jan 2. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |