routine screening for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
LMC Diabetes & Endocrinology Ltd., Toronto, Canada
Type 2 Diabetes Mellitus+5 More
routine screening - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment for NASH is safe and effective.

See full description

Eligible Conditions

  • Type 2 Diabetes Mellitus
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Type 2 Diabetes Mellitus

Study Objectives

This trial is evaluating whether routine screening will improve 1 primary outcome and 25 secondary outcomes in patients with Type 2 Diabetes Mellitus. Measurement will happen over the course of 1 day.

1 day
Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score
Alcohol consumption by study arm - drinks per day
Alcohol consumption by study arm - drinks per week
Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values
3 months
Prevalence of presumed advanced NASH based on biochemical and FibroScan results
Proportion of study participants with presumed any NASH
36 months
Alcohol consumption at 36 months - Alcohol Use Disorders Identification Test (AUDIT) score
Alcohol consumption at 36 months - drinks per day
Alcohol consumption at 36 months - drinks per week
Change in FibroScan-AST (FAST) score at 36 months among participants with stage F3-F4
Change in NAFLD fibrosis score (NFS) at 36 months among participants with stage F3-F4
Change in body mass index (BMI) at 36 months among participants with stage F3-F4
Change in controlled attenuation parameter (CAP) score at 36 months among participants with stage F3-F4
Change in diastolic blood pressure at 36 months among participants with stage F3-F4
Change in fibrosis-4 index (FIB-4) at 36 months among participants with stage F3-F4
Change in glycated hemoglobin (HbA1c) at 36 months among participants with stage F3-F4
Change in health-related quality of life at 36 months among participants with stage F3-F4 compared to stage F0-F2
Change in liver stiffness measure (LSM) at 36 months among participants with stage F3-F4
Change in number of diabetes medications at 36 months among participants with stage F3-F4
Change in systolic blood pressure at 36 months among participants with stage F3-F4
Change in waist circumference measurement at 36 months among participants with stage F3-F4
Comparison of any stage fibrosis
Comparison of fibrosis-4 index (FIB-4) and NAFLD fibrosis score (NFS) above cut-offs
Health-related quality of life at 36-months compared to baseline
Patient adherence to care path
Proportion of patients who undergo liver biopsy and have a diagnosis of any stage fibrosis at 36 months

Trial Safety

Safety Progress

1 of 3

Other trials for Type 2 Diabetes Mellitus

Trial Design

2 Treatment Groups

physician-driven screening group
1 of 2
routine screening group
1 of 2
Active Control
Experimental Treatment

This trial requires 5000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Routine Screening is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

routine screening group
Other
consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2)
physician-driven screening group
Other
consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 months for reporting.

Closest Location

LMC Diabetes & Endocrinology Ltd. - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical diagnosis of T2D
Age 18 - 80 years
BMI >25 kg/m2 or waist circumference ≥102 cm in men and ≥88 cm in women
Informed consent

Patient Q&A Section

Can nonalcoholic steatohepatitis be cured?

"There is no cure for NASH. The primary risk factor for steatohepatitis is lifestyle, and these patients must reduce their BMI. The role of the diet is not clearly defined. The use of statins could provide benefit in patients with more advanced disease. Lifestyle modification remains the most important treatment strategy." - Anonymous Online Contributor

Unverified Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

"More than 50,000-70,000 Americans are diagnosed with NAFLD annually. NAFLD has emerged as the second most frequent cause of advanced fibrosis in the United States, after HCV." - Anonymous Online Contributor

Unverified Answer

What is nonalcoholic steatohepatitis?

"In a group of patients with a body mass index below 28 kg/m(2), nonalcoholic steatohepatitis was not associated with impaired fasting glucose with diabetes mellitus II, and in this group, nonalcoholic steatohepatitis should not be considered a risk factor for impaired fasting glucose. In patients with a body mass index above 28 kg/m(2) and nonalcoholic steatohepatitis, impaired fasting glucose with diabetes mellitus II should be considered a risk factor for nonalcoholic steatohepatitis." - Anonymous Online Contributor

Unverified Answer

What are the signs of nonalcoholic steatohepatitis?

"The signs and symptoms of steatohepatitis are similar to those of chronic hepatitis C. In a diagnosis of steatohepatitis, a biopsy will be indicated in most patients." - Anonymous Online Contributor

Unverified Answer

What causes nonalcoholic steatohepatitis?

"In both men with and without obesity, genetic tendencies play a part in the development of NASH. This implies an active process in obesity itself. Nonalcoholic fatty liver disease is a key in the pathogenesis of NASH." - Anonymous Online Contributor

Unverified Answer

What are common treatments for nonalcoholic steatohepatitis?

"The present study revealed that, contrary to widely held belief, no one nonalcoholic steatohepatitis drug or treatment is ideal and that there is no'standard' therapy, although there are treatments that can be used for the majority of cases." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for nonalcoholic steatohepatitis?

"The majority of patients with NASH failed to maintain remission long-term, and thus, the patients should not meet a high index of certainty before the clinical trials." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating nonalcoholic steatohepatitis?

"There has been a significant amount of progress over the past few decades in treatment options for NASH. Novel therapies, such as endoscopic balloon dilation/remodeling of strictured portions of the esophagus or the liver ducts, are currently in Phase 2 or 3 clinical trials. Other treatments that are being intensively researched are lipid-liver specific agents, thiazolidinediones, and more specifically PPARgamma." - Anonymous Online Contributor

Unverified Answer

Does routine screening improve quality of life for those with nonalcoholic steatohepatitis?

"Although the screening of nonalcoholic steatohepatitis patients with a simple questionnaire is effective at detecting those with abnormal liver biochemistry, it does not significantly improve a patient's quality of life." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in routine screening for therapeutic use?

"The USFDA approved a more specific diagnostic algorithm in June 2015; this algorithm is no longer used in the United States. As of January 2016, the USFDA approved two additional diagnostic tests for routine use: the elastography test for jaundice to guide treatment, and the combination Hepatitis C/HIV test as part of routine screening.\n\nFindings from a recent study of a study were first published September 4, 2017 in Archives of Internal Medicine. The study, based on a database of 1.5 million U.S. hospitalizations, identified a 7-fold increase in patients hospitalized for nonalcoholic fatty liver disease (NAFLD) within a year after diagnosis of Parkinson's disease." - Anonymous Online Contributor

Unverified Answer

What is routine screening?

"Patients with known or suspected liver disease who are undergoing evaluation for suspected NAFLD often have abnormal liver tests and ultrasound findings that could indicate NAFLD and NASH. In this cohort, all patients who received any screening for liver disease were appropriately screened (biopsy in 46% of patients). None of these patients went on to have a true diagnosis of NASH with or without concurrent liver disease. Thus, the addition of a baseline ultrasound screening scan to standard laboratory testing was not associated with increased diagnostic yield." - Anonymous Online Contributor

Unverified Answer

Has routine screening proven to be more effective than a placebo?

"Routine screening of the general population with ultrasonography and magnetic resonance imaging may be more effective than a placebo intervention in the detection of asymptomatic or occult NASH." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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