Clinical Trials Logo

Clinical Trial Summary

The study is stratified cluster randomized trial (Phase 1) and prospective cohort study and NASH registry (Phase 2). The study population will include adults with T2D and presumed advanced NASH.


Clinical Trial Description

The study is a multi-centered, stratified cluster randomized controlled, open-labeled two-phase study. Clusters will be independent LMC clinic sites with patients as participants. The use of the stratified cluster randomization design will help prevent the potential for cross-contamination of screening methods. The study consists of two phases. For Phase 1, study participants who meet eligibility criteria undergo NASH screening. Everything, other than routineness of screening, is maintained the same in both the groups. The screening intervention received is determined by the site of the participant's provider. All participants enrolled undergo biochemical screening. In Phase 2, all participants, regardless of randomization, meeting biochemical cut-offs (FIB-4 index >2.67 or NFS >0.675) will undergo FibroScans at Phase 2 initiation and at the 36-month follow-up visit. Clinical data and a health-related quality of life assessment are collected at baseline and 36 months. A prospective NASH registry will be created from the participant data collected in Phase 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05029583
Study type Interventional
Source LMC Diabetes & Endocrinology Ltd.
Contact Lisa Chu, PhD
Phone 416-268-8787
Email [email protected]
Status Recruiting
Phase N/A
Start date August 11, 2021
Completion date June 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Recruiting NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A
Completed NCT04053959 - Artificial Intelligence Assisted Insulin Titration System Phase 4
Recruiting NCT04365400 - TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients Phase 2
Recruiting NCT03130244 - Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes N/A
Recruiting NCT04383639 - Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes N/A
Recruiting NCT05040087 - Changing the Natural History of Type 2 Diabetes ("CHANGE" Study) N/A
Not yet recruiting NCT04931836 - The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults N/A
Not yet recruiting NCT05026528 - Randomized Controlled Trial of Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes N/A
Recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02809365 - FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients N/A
Not yet recruiting NCT02900417 - Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes N/A