RECRUITING

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

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Conditions

Diabetes Mellitus, Type 2Endothelial DysfunctionSodium-Glucose Cotransporter-2 (SGLT2) inhibitorDapagliflozinEndothelial cell (EC) HealthVascular functionEC gene expression levelsCirculating miRNABiomarkers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-31
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05139914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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%
  2. * Body mass index (BMI) \>25
  3. * Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
  1. * Treatment with anticoagulation
  2. * Treatment with SGLT-2 inhibitor
  3. * HbA1c \>9.5% within the last 3 months
  4. * Systolic blood pressure less than 120mm Hg
  5. * History of genital mycotic infections: more than one genital mycotic infection in the past two years
  6. * History of recurrent urinary tract infections: history of chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
  7. * History of allergy to SGLT-2 inhibitor
  8. * History of bladder cancer or prior pelvic radiation
  9. * More than one hypoglycemic events in the past 6 months and/or HbA1c \<7.0%
  10. * Women lactating or pregnant. All women with childbearing potential will undergo a blood pregnancy test at each visit to exclude pregnancy.
  11. * Treatment with an investigational product within the last 30 days.
  12. * 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

Contacts and Locations

Study Contact

Naomi Hamburg, MD
CONTACT
(617) 638-7260
nhamburg@bu.edu

Principal Investigator

Naomi M Hamburg, MD
PRINCIPAL_INVESTIGATOR
BU School of Medicine, Cardiovascular Medicine

Study Locations (Sites)

BU School of Medicine Evans 748
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Naomi M Hamburg, MD, PRINCIPAL_INVESTIGATOR, BU School of Medicine, Cardiovascular Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-31
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-05-31
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor
  • Dapagliflozin
  • Endothelial cell (EC) Health
  • Vascular function
  • EC gene expression levels
  • Circulating miRNA
  • Biomarkers

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Endothelial Dysfunction