search
Back to results

Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Primary Purpose

Liver Cirrhosis, Diabetes

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Insulin Degludec and Insulin Aspart
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver cirrhosis, diabetes, time in range, insulin intensive therapy, new combination therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xiaolong ZhaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group with new combination therapy

group with intensive insulin therapy

Arm 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.

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

Outcomes

Primary Outcome Measures

time in range
time in range
Blood lactic acid level
Blood lactic acid level
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

Secondary Outcome Measures

mean blood glucose
mean blood glucose
Time above range
Time above range
Time below range
Time below range
Blood lactic acid
Blood lactic acid
Glycated Albumin
Glycated Albumin
three month mortality
three month mortality
Six month mortality
Six month mortality
Incidence rate of complications of liver cirrhosis within three months
Incidence rate of complications of liver cirrhosis within three months
Incidence rate of complications of liver cirrhosis within six months
Incidence rate of complications of liver cirrhosis within six months

Full Information

First Posted
November 6, 2022
Last Updated
November 29, 2022
Sponsor
Huashan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05641337
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Diabetes
Keywords
Liver cirrhosis, diabetes, time in range, insulin intensive therapy, new combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group with new combination therapy
Arm Type
Experimental
Arm 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.
Arm Title
group with intensive insulin therapy
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec and Insulin Aspart
Other Intervention Name(s)
metformin, linagliptin
Intervention 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. The control group was treated with traditional four needle insulin.
Primary Outcome Measure Information:
Title
time in range
Description
time in range
Time Frame
two weeks
Title
Blood lactic acid level
Description
Blood lactic acid level
Time Frame
two week
Title
Compound adverse events
Description
includetimes of hypolgycemia attack,severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week
Time Frame
two week
Secondary Outcome Measure Information:
Title
mean blood glucose
Description
mean blood glucose
Time Frame
two weeks
Title
Time above range
Description
Time above range
Time Frame
two weeks
Title
Time below range
Description
Time below range
Time Frame
two weeks
Title
Blood lactic acid
Description
Blood lactic acid
Time Frame
two weeks
Title
Glycated Albumin
Description
Glycated Albumin
Time Frame
two week
Title
three month mortality
Description
three month mortality
Time Frame
three months
Title
Six month mortality
Description
Six month mortality
Time Frame
six months
Title
Incidence rate of complications of liver cirrhosis within three months
Description
Incidence rate of complications of liver cirrhosis within three months
Time Frame
three months
Title
Incidence rate of complications of liver cirrhosis within six months
Description
Incidence rate of complications of liver cirrhosis within six months
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolong Zhao, PhD
Phone
13501827230
Email
xiaolongzhao@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duoduo Qu, Master
Phone
19852812469
Email
quduoduonju@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolong Zhao, PhD
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Xiaolong Zhao
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolong Zhao, PhD
Phone
13501827230
Email
xiaolongzhao@163.com
First Name & Middle Initial & Last Name & Degree
Duoduo Qu, master
Phone
19852812469
Email
quduoduonju@163.com
First Name & Middle Initial & Last Name & Degree
Xiaolong Zhao, PhD

12. IPD Sharing Statement

Learn more about this trial

Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

We'll reach out to this number within 24 hrs