Effect of Exenatide on Liver and Heart Fat and Inflammation
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Intervention: Exenatide; Glipizide
Intervention description: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.; Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.
Intervention MeSH terms: Exenatide; Glipizide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes

Summary:

      The purpose of this study is to examine the effect of exenatide on liver and heart
      (myocardial) fat and inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be able to communicate meaningfully with the investigator and must be
             legally competent to provide written informed consent.

          2. Patients may be of either sex. Female patients must be non-lactating and must either
             be at least two years post-menopausal, or be using adequate contraceptive precautions.

          3. Patients must range in age from 30 to 70 years, inclusive.

          4. Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997
             Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis
             of type 2 diabetes mellitus.

          5. Patients must be on diet therapy and/or metformin treatment for type 2 diabetes
             (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl

          6. Patients must have Hematocrit greater than 34 vol%.

          7. Subjects whose body weight has been stable over the three months prior to study
             enrollment will be included.

        Exclusion Criteria:

          1. Patients must not have type 1 diabetes.

          2. Patients must not have a fasting plasma glucose greater than 260 mg/dl.

          3. Patients must not have received a thiazolidinedione for at least 3 months prior to
             randomization.

          4. Patients must not be on insulin treatment or have received insulin for more than one
             week within the previous year prior to entry. Patients should not be on sulfonylureas,
             sitagliptin, or exenatide treatment.

          5. Patients taking systemic glucocorticoids or other medications known to affect glucose
             tolerance are excluded.

          6. Patients taking medications that affect gastrointestinal motility will be excluded.

          7. Patients with a history of Congestive Heart Failure, or clinically significant
             cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).