Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2010-07-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
Exenatide
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
Placebo
Placebo was administered in random order 30 min before OGTT-PET study in the same subject
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 .
Exenatide
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
Placebo
Placebo was administered in random order 30 min before OGTT-PET study in the same subject
Interventions
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Exenatide
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
Placebo
Placebo was administered in random order 30 min before OGTT-PET study in the same subject
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
65 Years
MALE
No
Sponsors
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Amylin Pharmaceuticals, LLC.
INDUSTRY
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Ralph DeFronzo
Professor
Principal Investigators
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Amalia Gastaldelli, PhD
Role: PRINCIPAL_INVESTIGATOR
UTHSCSA, San Antonio, TX
Locations
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Texas Diabetes Institute and UTHSCSA
San Antonio, Texas, United States
Countries
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References
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Daniele G, Iozzo P, Molina-Carrion M, Lancaster J, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Gastaldelli A. Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System. Diabetes. 2015 Oct;64(10):3406-12. doi: 10.2337/db14-1718. Epub 2015 Jun 26.
Gastaldelli A, Gaggini M, Daniele G, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Iozzo P. Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study. Hepatology. 2016 Dec;64(6):2028-2037. doi: 10.1002/hep.28827.
Other Identifiers
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233-GAS-08
Identifier Type: -
Identifier Source: org_study_id