Oral Glucose Tolerance Testing (OGTT) on Patients Taking Somatostatin Analogs

Acromegaly Clinical Trial

Official title:

Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01371045
• Other study ID #: Pro00024880
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 9, 2011
• Start date: June 2011

Study information

• Verified date: June 2011
• Source: Cedars-Sinai Medical Center
• Contact: Hershel Bhadsavle
• Phone: (310) 423-2830
• Email: hershel.bhadsavle[@]cshs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis of Diabetes Mellitus (Type 1 or Type 2)

• Use of medication for the treatment of insulin resistance or diabetes

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acromegaly

Intervention

Other:
• Oral Glucose Tolerance Test (OGTT)
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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center, Pituitary Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Arafat AM, Möhlig M, Weickert MO, Perschel FH, Purschwitz J, Spranger J, Strasburger CJ, Schöfl 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

ROTH J, GLICK SM, YALOW RS, BERSON SA. Secretion of human growth hormone: physiologic and experimental modification. Metabolism. 1963 Jul;12:577-9. — View Citation

Rubeck KZ, Madsen M, Andreasen CM, Fisker S, Frystyk J, Jørgensen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth hormone response to OGTT	assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects	2 hours	No