Status:
UNKNOWN
The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics
Lead Sponsor:
RenJi Hospital
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective, randomized, open-label, active drug controlled clinical trial that aims to compare the effects of henagliflozin or metformin on myocardial tissue level characteristics in type 2...
Detailed Description
MRI scanning will be assessed at baseline and at the end of the treatment period in order to to assess the cardiac morphology, cardiac function, and myocardial tissue characteristics. The cardiac MRI ...
Eligibility Criteria
Inclusion
- Individuals with type 2 diabetes newly diagnosed based on the WHO (1999) criteria;
- Hemoglobin A1c levels \>=7.0% and \<=8.0%;
- Females or males ≥18 years up to 75 years of age.
Exclusion
- Females or males \<18 years.
- Clinical diagnosis of type 1 diabetes and other types of diabetes.
- Blood pressure at screening that would require a change in blood pressure treatment over the study period.
- History of stroke or other clinically significant cerebrovascular disease.
- Any of the following cardiovascular diseases:
- Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
- Unstable heart failure or any heart failure with NYHA class III and IV
- Significant valvular disease
- Significant peripheral artery disease
- Active malignancy requiring treatment at the time of visit 0.
- Patients with severe hepatic impairment.
- Unstable or rapidly progressing renal disease.
- Ongoing treatment with loop diuretics.
- Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m2.
- Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06059287
Start Date
October 1 2023
End Date
December 31 2025
Last Update
September 28 2023
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