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Effect of Exenatide on Brain, Adipose Tissue, Pancreas, and Liver Function

This study is currently recruiting participants.
Verified January 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01588418
First received: March 19, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Impaired Glucose Tolerance
Diabetes
 Drug: Exenatide or placebo
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males age 18-65 years old
  2. Patients must have 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
    • AST (SGOT): ≤ 2.5 times upper limit of normal
    • ALT (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588418

Contacts
Contact: Sandra Martinez 210-358-7200

Locations
United States, Texas
Texas Diabetes Institute and UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact     210-358-7200        
Principal Investigator: Amalia Gastaldelli, PhD            
Sub-Investigator: Nicolas Musi, MD            
Sub-Investigator: Eugenio Cersosimo, MD            
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Amalia Gastaldelli, PhD UTHSCSA, San Antonio, TX
  More Information

No publications provided

Responsible Party: Ralph DeFronzo, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588418     History of Changes
Other Study ID Numbers: 233-GAS-08
Study First Received: March 19, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Impaired glucose tolerance
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperglycemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013