| Trial ID: | L0593 |
| Source ID: | JPRN-UMIN000020544
|
| Associated Drug: |
Tofogliflozin
|
| Title: |
Pleiotropic Effects and Safety of Sodium glucose co-transporter 2 inhibitor versus sulfonylurea in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver - SGLT2 Inhibitor versus Sulfonylurea on Type 2 Diabetes with NAFLD
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes and Non-alcoholic Fatty Liver
|
| Interventions: |
SGLT2 inhibitor dosage (Tofogliflozin): a dose of 20mg once daily for 48 weeks.<br> dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily.
|
| Outcome Measures: |
1. The improvement in histologic features of NAFLD, as assessed with a composite of standardized scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Disease activity is assessed with the nonalcoholic fatty liver disease activity score, which is based on a standardized grading system for steatosis (on a scale of 0 to 3), lobular inflammation (on a scale of 0 to 3), and hepatocellular ballooning (on a scale of 0 to 2), with higher scores indicating increasing severity.Change from baseline in liver enzymes<br>Change from baseline in body composition<br>Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test<br>Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study<br>Change from baseline in lipid profile<br>Change from baseline in renal function and electrolyte balances<br>Change from baseline in oxidative stress<br>Change from baseline in cytokine (TNF-alpha, leptin, adiponectin) levels<br>Change from baseline in hepatokine (Selenoprotein P, LECT2) levels<br>Change from baseline in organ-specific fat accumulation<br>Change from baseline in oxidative and non-oxidative glucose disposal<br>Change from baseline in respiratory quotients<br>Change from baseline in energy expenditure<br>Change from baseline in autonomic nerve function. This is performed by power-spectrum analyses of heart rate variability<br>Changes from baseline in minerals and bone metabolism<br>Changes from baseline in endothelial functions <br>Changes from baseline in fatty acids profiles<br>Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response.<br>Changes from baseline in gene expression profiles in the liver and blood cells<br>Changes from baseline in microRNAs and exosome contents<br>Epigenomic changes from baseline in genes of the liver and blood cells
|
| Sponsor/Collaborators: |
Kanazawa university hospital
Department of Disease Control and Homeostasis
|
| Gender: |
All
|
| Age: |
20years-oldNot applicable
|
| Phases: |
Not selected
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Parallel Randomized
|
| Start Date: |
13/01/2016
|
| Completion Date: |
26/03/2018
|
| Results First Posted: |
--
|
| Last Update Posted: |
21 May 2019
|
| Locations: |
Japan
|
| URL: |
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023720
|
