NCT05139914Leállítva4. fázis
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 11.
Megadott ok: The study was halted early because of the inability to enroll participants.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Leállítva
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 4 (tényleges)
- Első benyújtás
- 2021. nov. 19.
- Kezdés
- 2022. máj. 31.
- Elsődleges befejezés
- 2025. febr. 4.
- Fő szponzor
- Boston University
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT05139914
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Korábbi kezelés
- Treatment with anticoagulation
- Treatment with SGLT-2 inhibitor
- History of bladder cancer or prior pelvic radiation
- Treatment with an investigational product within the last 30 days.
Más betegség
- 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
Laborértékek
- HbA1c >9.5% within the last 3 months
- More than one hypoglycemic events in the past 6 months and/or HbA1c <7.0%
- 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
Egyéb
- Systolic blood pressure less than 120mm Hg
- Women lactating or pregnant. All women with childbearing potential will undergo a blood pregnancy test at each visit to exclude pregnancy.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 30 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| BU School of Medicine Evans 748 | Boston | Egyesült Államok | Ismeretlen állapot |
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