Using of SGLt2 Inhibitors in Patients With Type 2 DM

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06268977
• Lead Sponsor: Assiut University

Brief Summary

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

- To detect the side-effects of SGLT2i

Detailed Description

Type 2 diabetes mellitus (T2DM) is a worldwide health problem, with a continuously increasing prevalence . Good management of blood glucose level is critical to delay progression of the underlying metabolic dysfunction and to reduce the risk of diabetic complications . Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a new class of antidiabetic drug acting by increasing urinary glucose excretion. First approved in 2014, SGLT2i have been widely used to treat patients with type 2 diabetes They are effective in reducing blood glucose, and surprisingly have shown benefits beyond glycaemic control .

Physicians have reported improved hypertension, heart failure, chronic kidney disease, fatty liver disease and obesity However, SGLT inhibitors are not magical drugs, and their use is not free of side effects ( Reported side effects include urinary tract infections, genital infection, dehydration, and hypotension, plus the usual side effects of antidiabetic medications as hypoglycemia . The optimum practical guideline for adding SGLT2 inhibitors to treatment regimens of patients with diabetes is controversial .Many local guidelines and treatment policies exist, yet we need to develop our own local policy at Assiut University hospitals to suit our patients needs and expectations, balancing between efficacy and side effects.

Study Timeline

• Study First Submitted: 2024-01-17
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-17
• Last Update Submitted: 2024-02-17
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Adults (≥18 years)
2. both genders ( male and female)
3. type 2 diabetic patients

Exclusion Criteria

1. history of svere hypoglycemia
2. patients with history of weight loss
3. Patients with history of recurrent UTI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of adding SGLTi on BMI	Six months	compare the effect on BMI ( weight in kg and height in m2) in SGLTi receivers and non SGLTi receivers.
Effect of adding SGLTi on BP	Six months	Compare the effect on blood pressure measurement ( SBP and DBP in mmHg) in SGLTi receivers and non SGLTi receivers