Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
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- STATUS
- Recruiting
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- End date
- Nov 5, 2023
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- participants needed
- 60
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- sponsor
- Nidae Alaa
Summary
A prospective, randomized, open-label, controlled clinical trial will be conducted at the endocrinology department - Ain Shams University (ASU) hospital. Sixty patients will be enrolled into the study. 30 of which will receive dapagliflozin 10mg tab once daily and the other thirty will receive their standard antidiabetic therapy for 12 weeks.
Description
All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility.
Eligible patients will be randomly assigned to one of the following 2 arms:
- Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
- Group 2 (Test group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.
A total of four visits one for baseline evaluation and one for end of study evaluation and two intermediate visits, the following will be performed in the visits:
- Clinical Evaluation
- Systolic and diastolic blood pressures recording.
- Plasma glucose measurement.
- Report any adverse effects that may appear
- Blood samples will be taken at baseline and at 12-week visits
- Follow up
Details
| Condition | Diabetic Retinopathy |
|---|---|
| Treatment | Dapagliflozin 10mg Tab plus another oral hypoglycemic agent, Two oral hypoglycemic agents other than dapagliflozin |
| Clinical Study Identifier | NCT05310916 |
| Sponsor | Nidae Alaa |
| Last Modified on | 5 July 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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