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

Withdrawn

• Conditions: Acromegaly
• Interventions: Other: Oral Glucose Tolerance Test (OGTT)

• Registration Number: NCT01371045
• Lead Sponsor: Cedars-Sinai Medical Center

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.

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Growth hormone response to OGTT	2 hours	assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects

Trial Locations

Locations (1)

Cedars-Sinai Medical Center, Pituitary Center; 🇺🇸 Los Angeles, California, United States