Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Diabetes; Liver Cirrhosis

Treatments: Drug: Insulin Degludec and Insulin Aspart

Study type: Interventional

Funder types: Other

Identifiers

NCT05641337

2022-10-cirrhosis with DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

group with new combination therapy

Experimental group

Description:

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.

Treatment:

Drug: Insulin Degludec and Insulin Aspart

group with intensive insulin therapy

Active Comparator group

Description:

group was treated with intensive insulin therapy.The initial total amount of insulin is 0.5U/kg, of which 40% is basal insulin and 20% is aspart insulin before three meals

Treatment:

Drug: Insulin Degludec and Insulin Aspart