Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Diabetes Clinical Trial

Official title:

Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641337
• Other study ID #: 2022-10-cirrhosis with DM
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2022
• Source: Huashan Hospital
• Contact: Xiaolong Zhao, PhD
• Phone: 13501827230
• Email: xiaolongzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.

Description:

Cirrhosis with diabetes refers to the increase of blood sugar in cirrhosis, including cirrhosis before or after diabetes. It has a special pathophysiological mechanism that liver factors participate in blood glucose regulation. Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin, ,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis from multiple links. After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis of such patients, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Insulin Degludec and Insulin Aspart
The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. The control group was treated with traditional four needle insulin.

Locations

Country	Name	City	State
China	Xiaolong Zhao	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time in range	time in range	two weeks
Primary	Blood lactic acid level	Blood lactic acid level	two week
Primary	Compound adverse events	includetimes of hypolgycemia attack,severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week	two week
Secondary	mean blood glucose	mean blood glucose	two weeks
Secondary	Time above range	Time above range	two weeks
Secondary	Time below range	Time below range	two weeks
Secondary	Blood lactic acid	Blood lactic acid	two weeks
Secondary	Glycated Albumin	Glycated Albumin	two week
Secondary	three month mortality	three month mortality	three months
Secondary	Six month mortality	Six month mortality	six months
Secondary	Incidence rate of complications of liver cirrhosis within three months	Incidence rate of complications of liver cirrhosis within three months	three months
Secondary	Incidence rate of complications of liver cirrhosis within six months	Incidence rate of complications of liver cirrhosis within six months	six months