Acute Effect of Exenatide on Brain Glucose Metabolism

October 19, 2017 updated by: Ralph DeFronzo, The University of Texas Health Science Center at San Antonio

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

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Texas Diabetes Institute and UTHSCSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Males age 18-65 years old
  2. Patients must have Body Mass Index (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
    • 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:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide first, then Placebo
Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.
Drug: Exenatide
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
Other Names:
  • Byetta
Drug: Placebo
Placebo was administered in random order 30 min before OGTT-PET study in the same subject
EXPERIMENTAL: Placebo first, then Exenatide
Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .
Drug: Exenatide
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
Other Names:
  • Byetta
Drug: Placebo
Placebo was administered in random order 30 min before OGTT-PET study in the same subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
120 minutes after exenatide or placebo injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes after exenatide or placebo injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Amylin Pharmaceuticals, LLC.

Investigators

  • Principal Investigator: Amalia Gastaldelli, PhD, UTHSCSA, San Antonio, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (ESTIMATE)

May 1, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233-GAS-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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