Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide; Pioglitazone
Intervention description: Type 2 diabetic subjects will be randomized to receive exenatide 10 micrograms injected subcutaneously twice daily for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.; Type 2 diabetic subjects will be randomized to receive pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
Intervention MeSH terms: Pioglitazone; Exenatide
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, an anti-diabetes medication,
      on liver fat and blood levels of proteins that influence liver fat.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must range in age from 30 to 70 years.

          2. Patients must be able to communicate meaningfully with the investigator and must be
             legally competent to provide written informed consent.

          3. 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
             or be surgically sterilized.

          4. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2
             diabetes mellitus.

          5. Patients must be on diet therapy alone and/or metformin treatment (stable dose) and
             have a fasting plasma glucose concentration between 126 and 260 mg/dl.

          6. Patients must have Hematocrit greater than 34%.

          7. Subjects whose body weight has been stable (±1 Kg) over the three months prior to
             study will be included.

        Exclusion Criteria:

        1, Type 1 diabetes.

        2. 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 (CHF), or clinically significant
        cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).