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

This study is ongoing, but not recruiting participants.
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: November 17, 2014
Last verified: November 2014

March 19, 2012
November 17, 2014
July 2010
July 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01588418 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Exenatide on Brain, Adipose Tissue, Pancreas, and Liver Function
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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Impaired Glucose Tolerance
  • Diabetes
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.
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).
Intervention: Drug: Exenatide or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
July 2015
July 2015   (final data collection date for primary outcome measure)

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)
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01588418
233-GAS-08
No
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Amylin Pharmaceuticals, LLC.
Principal Investigator: Amalia Gastaldelli, PhD UTHSCSA, San Antonio, TX
The University of Texas Health Science Center at San Antonio
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP