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The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia

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ClinicalTrials.gov Identifier: NCT02806999
Recruitment Status : Unknown
Verified June 2016 by Guangdong General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Drug: Berberine; Insulin Drug: Insulin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

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 Name: 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 Name: No other name




Primary Outcome Measures :
  1. 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.).


Secondary Outcome Measures :
  1. 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.)

  2. 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.


Other Outcome Measures:
  1. 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)

  2. 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.

  3. 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.

  4. Intensive care time [ Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery ]
  5. All cause mortality [ Time Frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery ]
  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806999


Contacts
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Contact: Liming Lei, M.D. 86-18688906579 anesthlei@sina.com
Contact: Xiaobing Liu, M.D. 86-15989201782 liuxb21@aliyun.com

Locations
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China, Guangdong
Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science Not yet recruiting
Guangzhou, Guangdong, China, 510085
Contact: Jian Zhuang, M.D.    86-13602884548    drzhuangjian5413@163.com   
Contact: Chengbin Zhou, M.D.    86-13822182178    zcbwwww@163.com   
Principal Investigator: Haiyun Yuan, M.D.         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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Principal Investigator: Weiping Xiong, M.D. Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science

Additional Information:
Publications:

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02806999     History of Changes
Other Study ID Numbers: HYYuan
20151025 ( Other Grant/Funding Number: Traditional Chinese Medicine Bureau of Guangdong Province )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Whether individual participant collected in this study data can be available depends on the participant's permission.
Keywords provided by Guangdong General Hospital:
Heart disease
Postoperative period
Hyperglycemia
Berberine
Insulin
Clinical trials as topic
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs