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Clinical Trial Details

Trial ID: L6186
Source ID: NCT02964715
Associated Drug: Empagliflozin
Title: The Effect of Empagliflozin on NAFLD in Asian Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes|NAFLD
Interventions: DRUG: Empagliflozin
Outcome Measures: Primary: Change in histological Grade as evaluated with Non-alcoholic Steatohepatitis Clinical Research Network Scoring System, liver biopsy, baseline, 6 months|Change in serum FGF 21, blood test, baseline and 6 months | Secondary: Change in fibroscan and elastography measure of liver stiffness, imaging, baseline and 6 months|Change in Liver enzymes, blood test - AST,ALT, gamma GT, baseline and 6 months|Change in steatosis, histological, baseline and 6 months|Change in lobular inflammation, histological, baseline and 6 months|Change in ballooning, histological, baseline and 6 months|Change in fibrosis, histological, baseline and 6 months|Change in metabolic outcome -HbA1c, serum concentration, baseline and 6 months|Change in metabolic outcome - fasting NEFA, serum concentration, baseline and 6 months|Change in metabolic outcome - fasting Tg, serum concentration, baseline and 6 months|Change in serum FGF 19, serum concentration, baseline and 6 months|Change in serum adiponectin, serum concentration, baseline and 6 months|Change in serum IL-6, serum concentration, baseline and 6 months|Change in serum TNF alpha, serum concentration, baseline and 6 months|Change in serum uric acid, serum concentration, baseline and 6 months|Change in MRI features of NASH, serum concentration, baseline and 6 months
Sponsor/Collaborators: Sponsor: University of Malaya
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2018-11
Results First Posted:
Last Update Posted: 2017-05-31
Locations: University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia
URL: https://clinicaltrials.gov/show/NCT02964715