Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 Diabetes Mellitus (T2DM) is a disease that interferes with the body's proper
      production and use of insulin, a hormone needed to convert sugar into usable energy. People
      with Type 2 Diabetes Mellitus (T2DM) are at a higher risk for certain cardiovascular
      diseases, including heart disease and stroke. Normal treatments for Type 2 Diabetes Mellitus
      (T2DM) target blood sugar levels only, but there is reason to believe that also targeting
      blood fat levels will improve both sugar metabolism and heart function in people with Type 2
      Diabetes Mellitus, (T2DM.) This study will determine the effectiveness of blood-fat lowering
      treatments along with blood-sugar control treatments in improving heart function and symptoms
      of people with Type 2 Diabetes Mellitus(T2DM), and if this varies between men and women.
    

Detailed description: 
      Type 2 Diabetes Mellitus, (T2DM) is the most common type of diabetes. In Type 2 Diabetes
      Mellitus (T2DM), the body does not properly process sugars and, as a result, there is an
      excess amount of sugar in the blood. Eventually, the high blood sugar levels can lead to
      heart disease, nerve damage, kidney problems, or blindness. Typical Type 2 Diabetes Mellitus
      (T2DM) treatments target maintenance of blood sugar levels. Previous studies on Type 2
      Diabetes Mellitus (T2DM) have indicated that in people who have high amounts of fats in the
      blood, the body relies more heavily on fats than sugars as an energy source. This dependence
      on fats for energy has been shown to have a negative effect on heart function. There is
      reason to believe that lowering the levels of fats in the blood will enhance the ability of
      the heart and the whole body to efficiently use both fats and sugars as energy sources. This
      study will evaluate the effectiveness of treatment strategies that are designed to reach
      target levels of sugar and fat in the blood for treating people with Type 2 Diabetes Mellitus
      (T2DM).

      Participation in this double-blind study will last between 4 and 6 months. First,
      participants will undergo a medical screening and medication adjustment period, expected to
      last 6 months. The medical screening, lasting about 1 hour, will involve completing a medical
      history, physical exam, pregnancy test if applicable, and blood test to measure various
      factors that contribute to diabetes control. Participants will also be asked permission to
      store 1 tablespoon of their blood for up to 10 years to be used in future studies concerning
      genetics and heart energy metabolism. During the medication adjustment period, study
      physicians will adjust the participants' medications, offer advice on diabetes education and
      nutrition, and record any side effects from the medications. For newly diagnosed Type 2
      Diabetes Mellitus (T2DM) participants, the study physician may recommend medication changes
      to assure a hemoglobin A1c (HgA1c) level of less than 7.5%. If participants have already
      achieved this level, they will be asked to continue present medications and to also begin
      taking the medication metformin for the 30 days before they undergo several imaging studies.
      Next, participants will complete routine tests that evaluate the pumping function of the
      heart, including an electrocardiogram (ECG) performed before and during exercise, a body
      composition study using a dual energy x-ray absorptiometry (DEXA) scan, and a magnetic
      resonance imaging (MRI) test. Each of these tests will last between 30 and 90 minutes.

      After the qualifying tests, participants will return for the first of two separate imaging
      days that will include the same tests. The second imaging day will occur at the end of the
      medication period, approximately 2 months after the first imaging day. The first tests will
      be a whole body metabolism study and a heart metabolism imaging study, performed
      simultaneously. The whole body metabolism study will involve the injection of two tracers of
      metabolism, one for glucose and one for fatty acids. The heart metabolism imaging study will
      involve a positron-emission tomographic (PET) scan to take pictures of the heart and will
      include blood draws. The final imaging test will be a resting echocardiogram (ECHO) to
      measure heart function.

      Following completion of the first day of imaging tests, participants will be randomly
      assigned to one of three possible treatment groups: Group A ,B, or C. Group A will take
      Metformin alone.Group B will take Metformin and Rosiglitazone. Group C will take Metformin
      and Lovaza. Participants will be seen monthly for the next 4 months, during which study
      medication will be distributed and blood pressure, heart rate, weight, and any side effects,
      such as lower extremity swelling, will be measured. If there is a noticeable increase in
      swelling, study physicians may adjust medication dosages. During visits at Months 2 and 4,
      blood samples will be taken to measure liver and organ function and HgA1c. At the completion
      of the 4-month medication treatment, participants will undergo repeat imaging tests. If
      needed, participants will be offered the opportunity to attend one or more follow-up visits
      to re-establish a medication routine.
    

Intervention name(s): Metformin; Rosiglitazone; Lovaza
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin is taken alone; Rosiglitizone is taken with Metformin; Lovaza is taken with Metformin
Other intervention name(s): Glumetza, Glucophage, Fortamet, Riomet; Advandia; Omega-3 acid ethyl esters
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type II Diabetes Mellitus; Diabetes; PET; Heart Metabolism; Lovaza