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WithdrawnNCT01371045Updated Feb 13, 2025

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

An observational study in Acromegaly, sponsored by Cedars-Sinai Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Cedars-Sinai Medical Center · Observational

Why this study was withdrawn
PI moved from the institution. Study did not enroll any patients.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Acromegaly

Keywords

  • Acromegaly
  • Growth Hormone
  • Carcinoid Syndrome
  • Somatostatin
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In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

Browse Acromegaly studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
  • Use of medication for the treatment of insulin resistance or diabetes
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Acromegaly

    Patients carrying the diagnosis of acromegaly who are on long-acting somatostatin for at least 3 months prior to study enrollment.

    Other: Oral Glucose Tolerance Test (OGTT)

  • Carcinoid Syndrome

    Patients carrying a diagnosis of carcinoid syndrome who are taking long-acting somatostatin for at least 3 months prior to study enrollment.

    Other: Oral Glucose Tolerance Test (OGTT)

  • Healthy Controls

    Other: Oral Glucose Tolerance Test (OGTT)

Interventions

  • OtherOral 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.

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What researchers measure

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

    Time frame: 2 hours

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Study locations

1 site
  • Cedars-Sinai Medical Center, Pituitary Center
    Los Angeles, California 90048, United States
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References and documents

Publications

  • 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. PubMed 5006772 ↗
  • 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. PubMed 20410227 ↗
  • 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. PubMed 12601629 ↗
  • 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. PubMed 19033371 ↗
  • 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. PubMed 20813787 ↗
  • 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. PubMed 13975314 ↗
  • 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. PubMed 18171702 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01371045
Responsible party
Odelia Cooper (Professor of Medicine, Cedars-Sinai Medical Center) — Principal investigator
First posted
Jun 10, 2011
Start date
Jun 2011 (estimated)
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Feb 13, 2025

Study contacts

Odelia Cooper
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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