Optimizing diabetes treatment for patients with liver cirrhosis

Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

This study is testing a new combination treatment for diabetes in people with liver cirrhosis to see if it works better than regular insulin therapy while keeping blood sugar levels safe.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05641337 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a new combination therapy for managing diabetes in patients with liver cirrhosis. The study aims to compare the effectiveness of a regimen that includes metformin, Ryzodeg, and an oral DDP IV enzyme inhibitor against traditional insulin-intensive therapy. The focus is on improving blood glucose control while minimizing the risks of hypoglycemia and lactic acidosis. Participants will be randomly assigned to receive either the new combination therapy or standard insulin treatment to evaluate outcomes related to blood sugar levels and complications of cirrhosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with liver cirrhosis and elevated blood sugar levels meeting diabetes criteria.

Not a fit: Patients with advanced liver disease, significant cardiac issues, or those on certain medications that affect blood glucose may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better blood sugar management and improved overall health outcomes for patients with liver cirrhosis and diabetes.

How similar studies have performed: While traditional insulin therapy has been widely used, this novel combination approach has not been extensively tested in similar studies, making it a potentially groundbreaking investigation.

Eligibility criteria

Inclusion Criteria:

* Liver cirrhosis
* Age 18-70 years
* Patients with elevated blood sugar who meet the diabetes standard or have been treated with hypoglycemic drugs
* random finger or venous serum blood glucose more than 14 mmol/L

Exclusion Criteria:

* Those unwilling to participate or unable to cooperate;
* Child-pugh score is greater than 12;
* Glomerular filtration rate\<60ml/min/1.73m2;
* Patients with cardiac insufficiency;
* Patients with asymptomatic hypoglycemia;
* Pregnant patients were excluded;
* Patients with advanced liver cancer;
* Blood pressure is less than 90/60mmHg;
* Chronic liver disease plus acute or subacute liver failure;
* Patients with drug induced blood glucose disorder, such as glucocorticoids, contraceptives, etc;
* fingertip oxygen saturation less than 95% without oxygen inhalation;
* Autoimmune liver cirrhosis is currently taking hormone.
* Type 1 diabetes.
* Pancreatogenic diabetes, such as primary hemochromatosis, hepatolenticular degeneration, alcoholic pancreatitis, autoimmune diseases involving the pancreas, etc.

Where this trial is running

Shanghai, Shanghai

• Xiaolong Zhao — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Xiaolong Zhao, PhD

Conditions: Liver Cirrhosis, Diabetes, Liver cirrhosis, diabetes, time in range, insulin intensive therapy, new combination therapy