Fatty Liver Study in Patients With Type II Diabetes
Condition: Type II Diabetes; Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: DPP4 inhibitor; Pioglitazone; Lantus insulin
Intervention description: Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.; Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.; Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pioglitazone; Sitagliptin Phosphate; Insulin Glargine; Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type II Diabetes; Nonalcoholic fatty liver

Summary:

      The primary objective of this trial is to measure changes in hepatic lipid content using
      three common alternative therapeutic strategies to improve glycemic control in patients with
      type 2 diabetes who are not controlled with metformin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has provided informed consent in a manner approved by the Institutional Review
             Board (IRB) and is willing and able to comply with the trial procedures.

          2. Adults at least 18 years of age at the time of consent.

          3. Have type 2 diabetes mellitus.

          4. Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to
             study enrollment.

          5. Have blood A1c >7.6% and < 8.5% within 3 months prior to study enrollment.

          6. Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver"
             within 1 year of study enrollment.

          7. Stable medication for lipid lowering, blood pressure control, dietary supplements,
             including vitamins, for at least 3 months.

          8. Women of Childbearing Potential must be willing and able to use acceptable forms of
             birth control while on the study.

        Exclusion Criteria:

          1. Currently taking medication that can affect glucose metabolism other than Metformin.

          2. History of Kidney diseases that, in the opinion of the investigator , would place the
             subject at increased risk of participation or plasma levels of creatinine > 1.4 for
             women and > 1.5 for men.

          3. History of Cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion
             of the investigator, would place the subject at increased risk of participation.

          4. Current alcohol consumption more than12 to 15 g of alcohol a day, or >12 oz of beer, 5
             oz of wine, or 1.5 oz of distilled spirits.

          5. History of heart failure.

          6. Concurrent participation on another research study

          7. Use of an investigational agent in the 30 days prior to signing informed consent.

          8. History of prior non-compliance or the presence or history of psychiatric conditions
             (including drug or alcohol addiction) that would, in the opinion of the investigator,
             make it difficult for the subject to comply with the study procedures or follow the
             investigators instructions.

          9. Females who are pregnant or lactating

         10. Current Diagnosis or History of Bladder Cancer