Effects of SGLT2 Inhibitor Therapy on Pancreatic and hepatic fat content in patients of Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/08/020909
- Lead Sponsor
- ASTRA ZENECA PHARMACEUTICAL INDIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Overweight & obese (BMI 23.0 -35 kg/m2) subjects aged 20-50 years with T2DM of less than 5 year duration with HbA1c <9% & on a stable dose of metformin and/or sulphonylureas over last 8 weeks
T2DM patients with poor glycaemic control (HbAâ??c > 9â??0%), hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, cardiac and kidney disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,substantial alcohol consumption ( >20 g/day for women or >30 g/day for men), Child-Pugh B/C cirrhosis, other causes of liver disease, confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E), and disorders such as a medical history of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,type 1 diabetes mellitus, patients requiring major drug intervention to maintain good glycemic control will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method