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

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status

Withdrawn

Conditions

Acromegaly

Treatments

Other: Oral Glucose Tolerance Test (OGTT)

Study type

Observational

Funder types

Other

Identifiers

NCT01371045
Pro00024880

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Acromegaly
Description:
Patients carrying the diagnosis of acromegaly who are on long-acting somatostatin for at least 3 months prior to study enrollment.
Treatment:
Other: Oral Glucose Tolerance Test (OGTT)
Carcinoid Syndrome
Description:
Patients carrying a diagnosis of carcinoid syndrome who are taking long-acting somatostatin for at least 3 months prior to study enrollment.
Treatment:
Other: Oral Glucose Tolerance Test (OGTT)
Healthy Controls
Treatment:
Other: Oral Glucose Tolerance Test (OGTT)

Trial contacts and locations

1

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Central trial contact

Hershel Bhadsavle; Billy Gellepis

Data sourced from clinicaltrials.gov

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