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Completed

NCT Number: NCT01588418

Acute Effect of Exenatide on Brain Glucose Metabolism

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Texas Diabetes Institute and UTHSCSA

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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)

Treatment and study plan

exenatide

Drug

Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study

Other names: Byetta

Placebo

Drug

Placebo was administered in random order 30 min before OGTT-PET study in the same subject

Primary outcomes

  1. Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

    Time frame: 120 minutes after exenatide or placebo injection

    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.

Secondary outcomes

  1. Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

    Time frame: 60 minutes after exenatide or placebo injection

    we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.

Registry information

Official study title

Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 1, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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