Clinical trial NCT05641337: Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes
Official title: Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver Cirrhosis
Diabetes
Keywords: Liver cirrhosis
diabetes
time in range
insulin intensive therapy
new combination therapy
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: time in range
timeFrame: two weeks
measure: Blood lactic acid level
timeFrame: two week
measure: Compound adverse events
timeFrame: two week
Secondary outcomes:
measure: mean blood glucose
timeFrame: two weeks
measure: Time above range
timeFrame: two weeks
measure: Time below range
timeFrame: two weeks
measure: Blood lactic acid
timeFrame: two weeks
measure: Glycated Albumin
timeFrame: two week
measure: three month mortality
timeFrame: three months
measure: Six month mortality
timeFrame: six months
measure: Incidence rate of complications of liver cirrhosis within three months
timeFrame: three months
measure: Incidence rate of complications of liver cirrhosis within six months
timeFrame: six months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaolong Zhao
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Xiaolong Zhao, PhD
role: STUDY_CHAIR
References: