Acute Effect of Exenatide on Brain Glucose Metabolism

Completed · Phase 4 · Has a placebo group

Conditions studied: Impaired Glucose Tolerance (IGT), Diabetes

In brief

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.

Key facts

Study ID

NCT01588418

Run by

The University of Texas Health Science Center at San Antonio

People needed

15

Starts

2010-07-01

Expected to finish

2015-07-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males age 18-65 years old
• Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
• 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
• Patients must have BMI of 25-40 kg/m2
• Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
• Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
• Patients must have the following laboratory values:
• Hematocrit ≥ 34 vol%
• Serum creatinine* ≤ 1.5 mg/dl in males and
• Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
• Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (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 Glomerular filtration rate (GFR) is >70 ml/min

You may not qualify if…

• Patients are excluded from participation in the study if they meet any of the following criteria:
• Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
• Patients with BMI over 40 and under 25
• Patient with age below 18 yrs and over 65 yrs
• Female subjects
• Patients with type 1 diabetes
• Patients treated for type 2 diabetes
• Subjects with normal glucose tolerance (NGT)

Where it is running

• Texas Diabetes Institute and UTHSCSA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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