Effect of Exenatide on Brain, Adipose Tissue, Pancreas, and Liver Function
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function|
- Effect of exenatide on brain glucose metabolism [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject. Brain glucose metabolism will be then correlated with insulin sensitivity, insulin secretion rates, glucose metabolism and lipolysis.
- Cerebral glucose metabolism [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To relate changes in cerebral glucose metabolism with insulin secretion, hepatic glucose production, glucose absorption and peripheral glucose clearance and lipolysis.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: PET with or without Exenatide injection
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).
Drug: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588418
|Contact: Sandra Martinez||210-358-7200|
|United States, Texas|
|Texas Diabetes Institute and UTHSCSA||Recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: Amalia Gastaldelli, PhD|
|Sub-Investigator: Nicolas Musi, MD|
|Sub-Investigator: Eugenio Cersosimo, MD|
|Principal Investigator:||Amalia Gastaldelli, PhD||UTHSCSA, San Antonio, TX|