Study of the effect of SGLT2 Inhibitors on oxidative stress parameters in Type II Diabetes Mellitus Patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/11/028806
- Lead Sponsor
- Dr Ankita Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients aged between 30-60 years of either gender
2.Type II DM with a duration of disease >= 3 years.
3.HbA1c level 7.0-9.5%
4.Patients who are SGLT2i naïve patients.
5.Type II DM patients on a stable 2 or 3 drug combinations for the past 3 months. The allowed combination will be Metformin + Sulphonylurea +/- gliptins in the following dosages;
Metformin 1000-2500mg/day
Glipizide 5-40mg/day
Glimepride 1-8 mg/day
Gliclazide 30- 120mg/day
Sitagliptin 100mg/day
Linagliptin 5mg/day
Vildagliptin 50-100mg/day
Teneligliptin 20-40mg/day
6.Subjects who agree to comply with the study procedures
1.History of hypersensitivity to the study drug.
2.Patients used glucagon-like peptide-1 agonists, or insulin in the past 12 weeks.
3.Patients with type 1 diabetes.
4.Subjects with history of liver disease (alanine aminotransferase, alkaline aminotransferase or alkaline phosphatase levels >3 times the upper limit of normal) or kidney disease (serum creatinine >1.1mg/dl)
5.History of chronic smoking or alcohol addiction.
6.Pregnant and lactating women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in oxidative stress markers (MDA, NO and glutathione levels)Timepoint: 0 Week,8 Week, 12 Week
- Secondary Outcome Measures
Name Time Method Change in HbA1c, FBS and PPBS levelsTimepoint: 0 Week, 12 Week;Change in total cholesterol, triglyceride levels, high-density lipoprotein concentration (HDL-c) and low-density lipoprotein concentration (LDL-c)Timepoint: 0 Week, 12 Week;Correlation of the concentration of iron, TIBC, and ferritin with oxidative stress markers.Timepoint: 0 Week, 12 Week;Incidence of adverse effects in the study populationTimepoint: 0 Week, 4 Week. 8 Week. 12 Week