Study Stopped
PI moved from the institution. Study did not enroll any patients.
Oral Glucose Tolerance Testing (OGTT) on Patients Taking Somatostatin Analogs
Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFebruary 13, 2025
February 1, 2025
8 years
June 9, 2011
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth hormone response to OGTT
assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects
2 hours
Study Arms (3)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of acromegaly or carcinoid syndrome
- Treatment with somatostatin analog therapy (must have established a stable dose of three or more injections on the same dose prior to study enrollment)
- Healthy control subjects
You may not qualify if:
- Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
- Use of medication for the treatment of insulin resistance or diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center, Pituitary Center
Los Angeles, California, 90048, United States
Related Publications (7)
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.
PMID: 5006772BACKGROUNDGiustina 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.
PMID: 20410227BACKGROUNDVierhapper 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.
PMID: 12601629BACKGROUNDCarmichael 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.
PMID: 19033371BACKGROUNDRubeck 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.
PMID: 20813787BACKGROUNDROTH 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.
PMID: 13975314BACKGROUNDArafat 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.
PMID: 18171702BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odelia Cooper
Cedars-Sinai Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 10, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
February 13, 2025
Record last verified: 2025-02