Effects of Dapagliflozin on Blood Vessel Health in Type 2 Diabetes
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
This study is testing if the diabetes medication dapagliflozin can improve blood vessel health in people with Type 2 diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05139914 on ClinicalTrials.gov |
What this trial studies
This study investigates how dapagliflozin, a Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor, affects vascular health in patients with Type 2 Diabetes Mellitus (T2DM). It employs a two-treatment, two-period crossover design where participants receive either dapagliflozin or a placebo for six weeks, followed by a washout period and then crossover to the alternate treatment. The study aims to assess changes in endothelial cell health, gene expression, and biomarkers to understand the cardiovascular benefits of SGLT2 inhibitors. The total duration for each participant is 14 weeks, including treatment and washout periods.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Type 2 Diabetes Mellitus for at least three months, with a BMI greater than 25 and specific glucose levels.
Not a fit: Patients currently on anticoagulation therapy, those with a history of certain infections, or those with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how dapagliflozin improves vascular health and reduces cardiovascular risks in patients with Type 2 Diabetes.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in improving cardiovascular outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- BU School of Medicine Evans 748 — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Naomi M Hamburg, MD — BU School of Medicine, Cardiovascular Medicine
- Study coordinator: Naomi Hamburg, MD
- Email: nhamburg@bu.edu
- Phone: (617) 638-7260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.