Effects of SGLT2 Inhibitor Therapy on Pancreatic and hepatic fat content in patients of Type 2 Diabetes Mellitus

Effects of Sodium Glucose Co-Transporter 2 Inhibitor Therapy on Pancreatic and hepatic fat content using 3.0 Tesla Magnetic Resonance Imaging Proton Density Fat Fraction Software in patients of Type 2 Diabetes Mellitus when treated according to current guidelines Protocol: Prospective Open Label Case Control 16 weeks Proof of Concept Study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020909

Enrollment

Registered

2019-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: SGLT2 INHIBITOR: dapagliflozin 10 mg, once daily, orally for 120 days Control Intervention1: not applicable: not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Participants who have completed 120 day intervention with SGLT 2 inhibitor therapy will be evaluated for decrease in pancreatic and hepatic fat percentage, through MRI (3.0 Tesla). We hypothesise the usage of SGLT2 inhibitor will decrease 5% of liver and 1% of pancreatic fat content.Timepoint: 120 days	—

Secondary

Measure	Time frame
Participants who are intervention with SGLT 2 inhibitor therapy will be evaluated for decrease in pancreatic and hepatic fat percentage, through MRI (3.0 Tesla).Timepoint: 90 days	—

Countries

India

Contacts

Public ContactAmerta Ghosh

FORTIS CDOC HOSPITAL

anoopmisra@gmail.com01149101222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026