Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: 5 mg tablet once daily for 12 weeks; 1 tablet daily for 12 weeks
Intervention MeSH terms: Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: endothelial cells; cellular biomarker; endothelial dysfunction

Summary:

      Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels
      which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the
      blood . Research has shown that improving the survival of these special blood cells may
      decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart
      disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine
      used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is
      in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown
      to increase EPCs in patients with Type 2 diabetes.

      Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately
      affects the repair and regeneration of the endothelium and that prompt intervention using
      saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse
      cardiovascular risk by improving EPC survival and function above and beyond adequate glucose
      metabolism control.
    

Eligibility criteria:

        Inclusion Criteria

          1. Adults aged 40-70 years.

          2. Diagnosis of type 2 diabetes within the previous 8 years using criteria of the
             American Diabetes Association

          3. Currently treated with no hypoglycemic agents other than a stable dose (>3 months) of
             metformin (≥1.0 to ≤2 grams daily).

          4. HbA1C between 6 to 9% (both inclusive)

          5. BMI 25 to 39.9 kg/m2 (both inclusive)

        Exclusion Criteria:

          1. Contraindications for moderate exercise

          2. Implanted devices (e.g., pacemakers) that may interact with Tanita scale

          3. Previous coronary or cerebrovascular event within 6 months of screening or active or
             clinically significant coronary and/or peripheral vascular disease.

          4. Low hematocrit <28 Units

          5. Pre-existing liver disease and/or ALT and AST >2.5X's UNL

          6. Kidney disease (serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/dL for
             women,Creatinine Clearance ≤50 mL/min)

          7. History of pancreatitis, or cancer (except basal cell carcinoma)

          8. Statin use started (or dose change) in the last 3 months.

          9. Use of oral or injectable anti-diabetic medication other than Metformin

         10. Use of any form of consistent-long term steroid medication (oral, inhaled injected or
             nasal) within the last 3 months

         11. Systolic BP> 140 mmHg and diastolic BP> 90 mmHg

         12. Active wounds or recent surgery within 3 months.

         13. Inflammatory disease, or current use of anti-inflammatory drugs

         14. triglycerides >400 mg/dL

         15. untreated hyper/hypothyroidism Additionally, patients who are active smokers, patients
             who are pregnant, nursing women, and post menopausal women who are on hormone
             replacement therapy will be excluded.

        Patients on low dose oral contraceptives will be allowed to participate as these
        formulations contain lesser amount of estrogens.