The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia

NCT ID: NCT02806999

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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.

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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Berberine; Insulin

Intervention Type: DRUG

Participants will receive 500mg Berberine twice a day for 8 days; Meanwhile，participants will also continue to receive intensive insulin therapy.

Insulin

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

Drug: Insulin

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

Participants will continue to receive intensive insulin therapy; Meanwhile, Participants will also receive a placebo twice a day for 8 days.

Interventions

Berberine; Insulin

Participants will receive 500mg Berberine twice a day for 8 days; Meanwhile，participants will also continue to receive intensive insulin therapy.

Intervention Type: DRUG

Insulin

Participants will continue to receive intensive insulin therapy; Meanwhile, Participants will also receive a placebo twice a day for 8 days.

Intervention Type: DRUG

Other Intervention Names

No other name; No other name

Eligibility 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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiping Xiong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science

Locations

Guangdong Cardiovascular Insititution, Guangdong General Hospital, Guangdong Academy of Medical Science

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Liming Lei, M.D.

Role: CONTACT

anesthlei@sina.com

86-18688906579

Xiaobing Liu, M.D.

Role: CONTACT

liuxb21@aliyun.com

86-15989201782

Facility Contacts

Jian Zhuang, M.D.

Role: primary

drzhuangjian5413@163.com

86-13602884548

Chengbin Zhou, M.D.

Role: backup

zcbwwww@163.com

86-13822182178

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10711923 (View on PubMed)

Geng FH, Li GH, Zhang X, Zhang P, Dong MQ, Zhao ZJ, Zhang Y, Dong L, Gao F. Berberine improves mesenteric artery insulin sensitivity through up-regulating insulin receptor-mediated signalling in diabetic rats. Br J Pharmacol. 2016 May;173(10):1569-79. doi: 10.1111/bph.13466. Epub 2016 Apr 5.

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Reference Type: BACKGROUND

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Related Links

https://clinicaltrials.gov/ct2/show/record/NCT00425009?term=berberine&rank=13

Click here for more information about this study: Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Other Identifiers

20151025

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HYYuan

Identifier Type: -

Identifier Source: org_study_id