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Acute Effect of Exenatide on Brain Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT01588418
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : May 25, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance (IGT) Diabetes Drug: Exenatide Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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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 Name: 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 Name: Byetta

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588418


Locations
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United States, Texas
Texas Diabetes Institute and UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Amylin Pharmaceuticals, LLC.
Investigators
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Principal Investigator: Amalia Gastaldelli, PhD UTHSCSA, San Antonio, TX
More Information
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Publications of Results:

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Responsible Party: Ralph DeFronzo, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588418    
Other Study ID Numbers: 233-GAS-08
First Posted: May 1, 2012    Key Record Dates
Results First Posted: May 25, 2017
Last Update Posted: November 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:
Impaired glucose tolerance (IGT)
Diabetes
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hypoglycemic Agents
 Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists