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

Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01371045
Enrollment
0
Registered
2011-06-10
Start date
2011-06-30
Completion date
2019-06-30
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly, Growth Hormone, Carcinoid Syndrome, Somatostatin

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.

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.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Growth hormone response to OGTT2 hoursassessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026