NCT02806999

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

June 6, 2016

Last Update Submit

June 16, 2016

Conditions

Hyperglycemia

Keywords

Heart diseasePostoperative periodHyperglycemiaBerberineInsulinClinical trials as topic

Outcome Measures

Primary Outcomes (1)

  • Evidence of effects of insulin and berberine on stress hyperglycemia

    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 Outcomes (2)

  • Synergy of insulin and berberine on stress hyperglycemia

    Within the first 10 days (plus or minus 3 days) after cardiac surgery

  • Mechanism of berberine on stress hyperglycemia

    Within the first 10 days (plus or minus 3 days) after cardiac surgery

Other Outcomes (8)

  • Stool frequency

    Within the first 10 days (plus or minus 3 days) after cardiac surgery

  • Incidence of hypoglycemia

    Within the first 10 days (plus or minus 3 days) after cardiac surgery

  • Assessment of ventricular function by ultrasound

    Within the first 10 days (plus or minus 3 days) after cardiac surgery

  • +5 more other outcomes

Study Arms (2)

Berberine; Insulin

EXPERIMENTAL

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

Insulin

ACTIVE COMPARATOR

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

Drug: Insulin

Interventions

Berberine; InsulinDRUG

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

Also known as: No other name
Berberine; Insulin
InsulinDRUG

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

Also known as: No other name
Insulin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510085, China

Location

Related Publications (11)

  • Donnor T, Sarkar S. Insulin- Pharmacology, Therapeutic Regimens and Principles of Intensive Insulin Therapy. 2023 Feb 15. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK278938/

    PMID: 25905175BACKGROUND

  • Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.

    PMID: 19465235BACKGROUND

  • van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

    PMID: 11794168BACKGROUND

  • Rassias AJ. Intraoperative management of hyperglycemia in the cardiac surgical patient. Semin Thorac Cardiovasc Surg. 2006 Winter;18(4):330-8. doi: 10.1053/j.semtcvs.2006.05.002.

    PMID: 17395030BACKGROUND

  • Lee YS, Kim WS, Kim KH, Yoon MJ, Cho HJ, Shen Y, Ye JM, Lee CH, Oh WK, Kim CT, Hohnen-Behrens C, Gosby A, Kraegen EW, James DE, Kim JB. Berberine, a natural plant product, activates AMP-activated protein kinase with beneficial metabolic effects in diabetic and insulin-resistant states. Diabetes. 2006 Aug;55(8):2256-64. doi: 10.2337/db06-0006.

    PMID: 16873688BACKGROUND

  • Wiener RS, Wiener DC, Larson RJ. Benefits and risks of tight glucose control in critically ill adults: a meta-analysis. JAMA. 2008 Aug 27;300(8):933-44. doi: 10.1001/jama.300.8.933.

    PMID: 18728267BACKGROUND

  • Monzillo LU, Hamdy O. Evaluation of insulin sensitivity in clinical practice and in research settings. Nutr Rev. 2003 Dec;61(12):397-412. doi: 10.1301/nr.2003.dec.397-412.

    PMID: 14968910BACKGROUND

  • Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.

    PMID: 10711923BACKGROUND

  • 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.

    PMID: 26914282BACKGROUND

  • Zhao GL, Yu LM, Gao WL, Duan WX, Jiang B, Liu XD, Zhang B, Liu ZH, Zhai ME, Jin ZX, Yu SQ, Wang Y. Berberine protects rat heart from ischemia/reperfusion injury via activating JAK2/STAT3 signaling and attenuating endoplasmic reticulum stress. Acta Pharmacol Sin. 2016 Mar;37(3):354-67. doi: 10.1038/aps.2015.136. Epub 2016 Jan 25.

    PMID: 26806299BACKGROUND

  • Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.

    PMID: 24671945BACKGROUND

Related Links

MeSH Terms

Conditions

HyperglycemiaHeart DiseasesInsulin Resistance

Interventions

BerberineInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCardiovascular DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Weiping Xiong, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liming Lei, M.D.

CONTACT

86-18688906579anesthlei@sina.com

Xiaobing Liu, M.D.

CONTACT

86-15989201782liuxb21@aliyun.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 21, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

CN(1)