Status:
COMPLETED
Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Type 2 Diabetes
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of pioglitazone to impr...
Detailed Description
The thiazolidinedione (TZD) class of drugs has been shown to improve insulin sensitivity in skeletal muscle, liver, and adipocytes and to have anti-inflammatory and cardioprotective effects. The beta ...
Eligibility Criteria
Inclusion
- Diabetic patients must be on diet therapy alone or diet plus a sulfonylurea, or diet plus metformin, or diet plus sulfonylurea/metformin and have a HbA1c ≥ 7.0%.
- Patients must have the following laboratory values:
- Hematocrit ≥ 34 vol% Serum creatinine ≤ 1.8 mg/dl AST (SGOT) ≤ 2 times upper limit of normal ALT (SGPT) ≤ 2 times upper limit of normal Alkaline phosphatase ≤ 2 times upper limit of normal
- Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
- Body weight must be stable (± 3-4 pounds) over the three months prior to study
- The normal healthy control group will be age, weight (BMI), and gender matched with the diabetic group and must have a normal OGTT according to ADA criteria.
- Subjects with IFG/IGT will have a FPG (100-125mg/dl) and/or 2-h plasma glucose (140-199mg/dl) according to ADA criteria.
Exclusion
- Patients must not have type 1 diabetes.
- Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c \> 10.0%.
- Patients must not have received a thiazolidinedione or insulin for more than one week during the year prior to randomization.
- Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00845182
Start Date
June 1 2007
End Date
July 1 2010
Last Update
January 18 2018
Active Locations (1)
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1
Barter Research Center, ALM VA Hospital
San Antonio, Texas, United States, 78229