Type 2 Diabetes
Conditions
Keywords
type 2 diabetes
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.
Interventions
DRUGSGLT2 inhibitor
a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-randomized (quasi-random, sequential) with two steps: First, Clinical Screening foe eligibility. Second, Sequential Allocation (based on the order of cleared medical enrollment: Odd-numbered cleared participants (e.g., 1, 3, 5...) will be allocated to the Experimental Arm and Even-numbered cleared participants (e.g., 2, 4, 6...) will be allocated to the Control Arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (≥18 years) 2. both genders ( male and female) 3. type 2 diabetic patients
Exclusion criteria
1. history of severe hypoglycemia 2. patients with history of weight loss 3. Patients with history of recurrent UTI 4. patients already receiving SGLT2i as part of their treatment 5. very high blood glucose (A1c more than 11%) or presenting at the clinic with BG above 300 mg/dL. 6. clinical evidence of dehydration. 7. Frailty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of adding SGLTi on HbA1c | Six months | Compare the effect on HbA1c between study arms |
| comparing CAP change between study arms | Six months | compare steatosis by FibroScan between study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of adding SGLTi on WC | Six months | compare the effect on waist circumference between study arms |
| comparing adverse-events between study arms | six months | comparing adverse-events between study arms |
| compare other metabolic parameters between study arms | six months | compare SBP, DBP, triglycerides, HDL-c, and LDL-c |
Countries
Egypt
Outcome results
None listed