The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia

June 16, 2016 updated by: Guangdong Provincial People's Hospital

The Therapeutic Effects of Combination of Insulin With Berberine on the Patients With Stess Hyperlipemia:a Prospective, Double Blind, Randomized, Placebo-controlled, Single-center Clinical Trial

Berberine is a conventional component in Chinese medicine. In recent years, effects of Berberine on improvement of glucose metabolism have been explored. The purpose of this study is to observe the therapeutic effects of combination of insulin and berberine on stress hyperglycemia in patients after cardiac surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients at risk for stress hyperglycemia are often prescribed insulin (Intensive insulin therapy, IIT and maintenance of blood glucose at a level between 80 and 110 mg per deciliter), which are the medication that reduce the level of glucose in the blood. By lowering the glucose level, these patients have a lower incidence of arrhythmia, myocardial ischemia and reperfusion injury, and heart failure and so on. But there are many patients whose hyperglycemia are not well controlled.If investigators are simply doubling the insulin, that only 10% of the benefit can be received.And it often bring significant side effects (Such as: hypoglycemia, etc.) in critically ill patients. Several studies have suggested that the use of berberine can effectively lowering the blood glucose level.The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of insulin and berberine on stress hyperglycemia in patients with heart disease whose level of blood glucose are not well controlled when only using insulin postoperatively.

This study will enroll postoperative patients who currently are injected with insulin by insulin pump，but the level of blood glucose is not controlled well. Patients will be assigned to receive 500mg of Berberine twice a day or a placebo(meanwhile they are receiving intensive insulin therapy) in a randomized, double blind, and prospective way. Investigators will occur at preoperative baseline, operating time and postoperative days 2, 4 and 8. Blood will be collected for laboratory testing, and acute physiology and chronic health evaluationⅡ and therapeutic intervention scoring system-28 will assess patient's condition at baseline and days 2, 4 and 8. At days 2, 4 and 8, medication efficacy will be also assessed and tests of blood glucose will be performed. Insulin count will be used to assess effectiveness of Berberine treatment at days 2, 4 and 8. Meanwhile, medication side effects will be monitored and the incidence of hypoglycemia or stool frequency are rigorously recorded at days 2, 4 and 8.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510085
        • Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haiyun Yuan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of stress hyperglycemia (fasting glucose >6.9 mmol/L or random glucose >11.1 mmol/L without evidence of previous diabetes);
  • Worsening glycemic control;
  • Individuals who had cardiac surgery before recruitment;
  • Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study;

Exclusion Criteria:

  • Individuals with a history of diabetes;
  • Individuals who are not able to cooperate;
  • Female of childbearing potential;
  • Severe liver or renal disease, or cancer history;
  • Individuals who are involved in designing, planning or performing this clinical trial;
  • Individuals with any condition that could be worsened by supplemental Berberine;
  • Individuals with severe gastrointestinal disease;
  • Individuals with infectious diseases;
  • Current participation in another clinical trial;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Berberine; Insulin

Follow the previous administration program，participants will continue to receive intensive insulin therapy; Besides injecting insulin, participants will receive 500mg berberine twice a day for 8 days.

Drug: Berberine; Insulin
Drug: Berberine; Insulin
Participants will receive 500mg Berberine twice a day for 8 days; Meanwhile，participants will also continue to receive intensive insulin therapy.
Other Names:
  • No other name
Active Comparator: Insulin

Besides receiving intensive insulin therapy, participants will take a placebo twice a day for 8 days.

Drug: Insulin
Drug: Insulin
Participants will continue to receive intensive insulin therapy; Meanwhile, Participants will also receive a placebo twice a day for 8 days.
Other Names:
  • No other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of effects of insulin and berberine on stress hyperglycemia
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Levels of blood glucose will be used to evaluate the hypoglycemic activity of berberine (Blood glucose is measured every 4 hours, and when patient's blood glucose are not stable, blood glucose can be measured every 1 hours.).
Within the first 10 days (plus or minus 3 days) after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Synergy of insulin and berberine on stress hyperglycemia
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Total dose of insulin (If there is synergy between insulin and berberine, the total dose of insulin should be reduced.)
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Mechanism of berberine on stress hyperglycemia
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Hyperinsulinaemic-euglycaemic clamp will be used to assess the improvement in insulin resistance and initially explore the mechanism of berberine hypoglycemic.
Within the first 10 days (plus or minus 3 days) after cardiac surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Evaluating the side effects of Berberine (Causing constipation)
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Incidence of hypoglycemia
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
If the incidence of hypoglycemia is reduced, we will conclude that berberine can reduce the side effects of intensive insulin treatment.
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Assessment of ventricular function by ultrasound
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
EF (ejection fraction) value will be measured by ultrasound to assess cardiac function.
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Intensive care time
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Within the first 10 days (plus or minus 3 days) after cardiac surgery
All cause mortality
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Assess the severity of the disease by APACHEⅡ
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
The full name of APACHEⅡ is acute physiology and chronic health Ⅱ, a questionnaire is used to acess the severity of the disease.
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Assess the nursing workload by TISS-28
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
The full name of TISS-28 is therapeutic intervention scoring system-28. It is a questionnaire used to assess the nursing workload in ICU patients, so TISS-28 can indirectly reflect patient's condition.
Within the first 10 days (plus or minus 3 days) after cardiac surgery
Incidence of nosocomial infections
Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery
Stress hyperglycemia leads to decreased immunity, and good blood glucose control helps to reduce nosocomial infections.
Within the first 10 days (plus or minus 3 days) after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Weiping Xiong, M.D., Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYYuan
  • 20151025 (Other Grant/Funding Number: Traditional Chinese Medicine Bureau of Guangdong Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Whether individual participant collected in this study data can be available depends on the participant's permission.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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