Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood vessels.

The overarching objective of this mechanistic study is to learn how a Sodium-Glucose Cotransporter-2 (SGT2) inhibitor, dapagliflozin, impacts vascular health in patients with Type 2 Diabetes Mellitus (T2DM). The investigators will compare the changes in vascular health to changes in endothelial cell (EC) phenotype including non-coding RNA (ncRNA) to develop evidence supporting the mechanism of cardiovascular benefit of SGLT2 inhibitors. This study will provide novel information regarding the mechanism of effects of novel treatments for endothelial function and vascular health in patients with T2DM to reduce cardiovascular (CV) risk. The research aims to assess the:

• effects of dapagliflozin on EC phenotype.

• impact of dapagliflozin on vasodilator function and additional measures of vascular health including arterial stiffness and circulating markers of vascular health.

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

Details

• Lead Sponsor: Boston University
• Collaborator: American Heart Association
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Diagnosis of T2DM for minimum of 3 months defined as fasting glucose greater than or equal to 120 mg/dL, hemoglobin A1C (HbA1C) ≥6.5%

• Body mass index (BMI) >25

• Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion Criteria:

• Treatment with anticoagulation

• Treatment with SGLT-2 inhibitor

• HbA1c >9.5% within the last 3 months

• Systolic blood pressure less than 120mm Hg

• History of genital mycotic infections: more than one genital mycotic infection in the past two years

• History of recurrent urinary tract infections: history of chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)

• History of allergy to SGLT-2 inhibitor

• History of bladder cancer or prior pelvic radiation

• More than one hypoglycemic events in the past 6 months and/or HbA1c <7.0%

• Women lactating or pregnant. All women with childbearing potential will undergo a blood pregnancy test at each visit to exclude pregnancy.

• Treatment with an investigational product within the last 30 days.

• Clinically evident major illness of other organ systems, including clinically evident cancer, renal failure (GFR<60 mL/min), or other conditions that in the opinion of the principal investigator make a clinical study inappropriate