Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Pioglitazone 15 mg daily: Participants in this group will receive standard care along with pioglitazone 15 mg once daily for 6 months. Lifestyle advice will be provided as per standard
Sponsors
Endocrine society of india
Eligibility
Inclusion criteria
Inclusion criteria: Males aged 18 to 60 years Diagnosis of T2DM as per ADA criteria on stable oral therapy HbA1c less than 7 at screening Ultrasound evidence of hepatic steatosis Able and willing to give informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: Estimated GFR less 45 NYHA class II to IV heart failure Prior or current bladder cancer Musculoskeletal or neurologic or other conditions precluding participation in the exercise program Alcohol intake more 30 g per day Active infection or malignancy or other significant medical illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the difference in handgrip strength from baseline to 6 months among the three randomized armsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in appendicular skeletal muscle mass index measured by bioelectrical impedance analysis from baseline to 6 months among the three armsTimepoint: 6 months;To compare the change in circulating serum irisin levels from baseline to 6 months among the three armsTimepoint: 6 months;To compare the change in hepatic steatosis from baseline to 6 months among the three armsTimepoint: 6 months;4. To evaluate the correlation between the change in handgrip strength, ASMI, and irisin with the change in CAP score.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDR SHAH NAWAZ
St Johns medical college
Outcome results
None listed