Status:
UNKNOWN
Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Nidae Alaa
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief 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...
Detailed 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 el...
Eligibility Criteria
Inclusion
- Female or male aged between 40 and 70 years old.
- Glomerular filtration rates \> 60 mL/min.
- Normal aspartate and alanine transaminase levels.
- Controlled systolic and diastolic blood pressures
Exclusion
- Patients using insulin or more than one oral anti-diabetic drug.
- Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level \>240 mg/dl.
- Patients with a history of cardiovascular events within six months before enrolment.
- Patients suffering from cataract or glaucoma.
- Patients with volume depletion clinical signs.
- Body mass index (BMI) \>40 kg/m2
- Infectious or inflammatory diseases.
- Neoplasm, or hematological disorders.
- Pregnant or breast-feeding patients.
- Active participation in another clinical study.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05310916
Start Date
June 6 2022
End Date
November 1 2023
Last Update
June 10 2022
Active Locations (1)
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1
Internal medicine and endocrinology department, Ain-shams university hospitals
Cairo, Egypt