Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Xiaolong Zhao
RECRUITING
Shanghai
Contact Information
Primary
Xiaolong Zhao, PhD
xiaolongzhao@163.com
13501827230
Backup
Duoduo Qu, Master
quduoduonju@163.com
19852812469
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 184
Treatments
Experimental: 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.
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov