Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Dapagliflozin: 10mg once daily for 6 months through oral route.
Control Intervention1: NIL: NIL
Sponsors
Dr. Vishal Roy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between age group of 18 to 65 years 2. Individuals with BMI more than 25 kg per square meter 3. Patient with known diabetes with HbA1C between 6.5 to 8.5 percent 4. Patients with FIB 4 score more than 1.4 5. Patient having deranged CAP or LSM value on fibroscan 6. Patient willing to participate in the study and give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with significant alcohol consumption per day male 30 grams per day female 20 grams per day 2. Patient on any medication known to affect weight in last 3 months 3. Patients having history of hepatic dysfunction 4. Patient having thyroid dysfunction 5. Patients taking any concurrent medications known to affect liver enzymes 6. Patient showing intolerance to dapagliflozin 7. Patients having recurrent urinary tract infection 8. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI, HbA1c, lipid profile, FIB-4, CAP, LSMTimepoint: At baseline and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Vishal Roy
MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra
Outcome results
None listed