Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Blood lactic acid level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
group with new combination therapy
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.
干预措施: Insulin Degludec and Insulin Aspart (Drug)
group with intensive insulin therapy
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
干预措施: Insulin Degludec and Insulin Aspart (Drug)
结局指标
主要结局
Blood lactic acid level
时间窗: two week
Blood lactic acid level
time in range
时间窗: two weeks
time in range
Compound adverse events
时间窗: two week
includetimes of hypolgycemia attack，severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week
次要结局
- Time above range(two weeks)
- Time below range(two weeks)
- three month mortality(three months)
- Six month mortality(six months)
- mean blood glucose(two weeks)
- Glycated Albumin(two week)
- Incidence rate of complications of liver cirrhosis within three months(three months)
- Incidence rate of complications of liver cirrhosis within six months(six months)
- Blood lactic acid(two weeks)
研究者
xiaolong zhao
Chief Physician
Huashan Hospital