The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia
The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia
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.
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.
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;