Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: George Washington University
• Collaborator: AstraZeneca
• Treatments: Saxagliptin

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.