Clinical Trial Details

Trial ID: L0821
Source ID: TCTR20170511001
Associated Drug: Dapagliflozin
Title: The effects of dapagliflozin on hepatic and visceral fat in type 2 diabetes patients with non-alcoholic fatty liver disease
Acronym: --
Status: Not Recruiting
Study Results: Has Results
Results: https://doi.org/10.1111/jgh.15580
Conditions: Non-alcoholic fatty liver disease Diabetes patient <br>NAFLD<br>DM type II<br>Insulin resistance<br>SGLT2 inhibitor<br>Fatty liver<br>;NAFLD<br>DM type II<br>Insulin resistance<br>SGLT2 inhibitor<br>Fatty liver<br>
Interventions: Dapagliflozin 10 mg Tablets&#44; Oral&#44; Once Daily&#44; 12 weeks,Matching placebo to Dapagliflozin 10 mg Tablets&#44; Oral&#44; Once Daily&#44; 12 weeks;Experimental Drug,Placebo Comparator Drug;Dapagliflozin,Placebo
Outcome Measures: To evaluate the effect of Dapagliflozin on improvement of NAFLD 12 weeks Liver attenuation index by Non&#45;contrast CT scanImprovement of NASH and metabolic parameters 12 weeks measured all fat area&#44; visceral fat area&#44; subcutaneous fat area and girth by semiautomatic software ,Improvement of body composition 12 weeks Body weight, Body mass index, waist circumference, visceral fat to subcutaneous fat ratio in non-contrast CT scans,Improvement od metabolic parameter 12 weeks HOMA-IR, Leptin, adiponectin and TNF-alpha
Sponsor/Collaborators: The Faculty of Medicine endownment Fund
Gender: All
Age: 18 Years75 Years
Phases: Phase 4
Enrollment: 40
Study Type: Interventional
Study Designs: Randomized
Start Date: 11/05/2017
Completion Date: 29/12/2017
Results First Posted: 12/06/2021
Last Update Posted: 7 February 2022
Locations: Thailand
URL: www.thaiclinicaltrials.org/show/TCTR20170511001