Overview

This trial is active, not recruiting.

Conditions impaired glucose tolerance, diabetes
Treatment exenatide or placebo
Phase phase 4
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator Amylin Pharmaceuticals, LLC.
Start date July 2010
End date July 2015
Trial size 15 participants
Trial identifier NCT01588418, 233-GAS-08

Summary

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).
exenatide or placebo
Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study) The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.

Primary Outcomes

Measure
Effect of exenatide on brain glucose metabolism
time frame: 12 weeks

Secondary Outcomes

Measure
Cerebral glucose metabolism
time frame: 12 weeks

Eligibility Criteria

Male participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Males age 18-65 years old 2. Patients must have BMI between 25 and 40 kg/m2 3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes. 4. Patients must have BMI of 25-40 kg/m2 5. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study. 6. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included. 7. Patients must have the following laboratory values: - Hematocrit ≥ 34 vol% - Serum creatinine* ≤ 1.5 mg/dl in males and - AST (SGOT): ≤ 2.5 times upper limit of normal - ALT (SGPT): ≤ 2.5 times upper limit of normal - Alkaline phosphatase ≤ 2.5 times upper limit of normal - If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the GFR is >70 ml/min Exclusion Criteria: Patients are excluded from participation in the study if they meet any of the following criteria: 1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease) 2. Patients with BMI over 40 and under 25 3. Patient with age below 18 yrs and over 65 yrs 4. Female subjects 5. Patients with type 1 diabetes 6. Patients treated for type 2 diabetes 7. Subjects with normal glucose tolerance (NGT)

Additional Information

Official title Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function
Principal investigator Amalia Gastaldelli, PhD
Description This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.