| Trial ID: | L7113 |
| Source ID: | NCT05042505
|
| Associated Drug: |
Dapagliflozin 10mg Tab
|
| Title: |
Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation
|
| Acronym: |
Dapa-LiT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Liver Transplant; Complications
|
| Interventions: |
DRUG: Dapagliflozin 10Mg Tab|DRUG: Sitagliptin 100mg
|
| Outcome Measures: |
Primary: Changes from baseline to month 12 in liver and pancreatic fat content., MRI PDFF will be performed before and at 12 months, 12 Month | Secondary: Change from baseline in body composition variables (body weight, BMI, body fat percentage, visceral adipose tissue, skeletal muscle mass and bone mineral content) at month 12. Body weight and BMI will be automatically recorded by the DEXA scan., DEXA will be performed before and at 12 months, 12 Months|Changes from baseline in liver aminotransferases (AST, ALT and GGT), Liver enzymes will be performed before, 6 months and at 12 months, 12 months|Changes in efficacy variables (proportion of individuals requiring insulin therapy at months 6 and 12, changes from baseline in HbA1c at months 6 and 12, and the percentage change from baseline in the total daily insulin dose at months 6 and 12)., Efficacy variables (proportion of individuals requiring insulin therapy at months 6 and 12, changes from baseline in HbA1c at months 6 and 12, and the percentage change from baseline in the total daily insulin dose at months 6 and 12) will be recorded in detail., 12 Months|Safety assessment at months 3, 6, 9 and 12, Safety parameters will be recorded before ,6 months and at 12 months, 12 Months
|
| Sponsor/Collaborators: |
Sponsor: Medanta, The Medicity, India
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-01-01
|
| Completion Date: |
2025-05-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-27
|
| Locations: |
Division Of Endocrinology & Diabetes, Medanta The Medicity, Gurgaon, Haryana, 122001, India
|
| URL: |
https://clinicaltrials.gov/show/NCT05042505
|
