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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01371045
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Acromegaly
Other: Oral Glucose Tolerance Test (OGTT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Growth hormone response to OGTT [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 36
Study Start Date: June 2011
Groups/Cohorts Assigned Interventions
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)
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.
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)
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.
Healthy Controls 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371045

Contacts
Contact: Hershel Bhadsavle (310) 423-2830 hershel.bhadsavle@cshs.org
Contact: Billy Gellepis 310-423-3395 Billy.Gellepis@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John Carmichael, M.D.         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John D Carmichael, M.D. Cedars-Sinai Medical Center
  More Information

Publications:

Responsible Party: John Carmichael, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01371045     History of Changes
Other Study ID Numbers: Pro00024880
Study First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Growth Hormone
Carcinoid Syndrome
Somatostatin

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014