Insulin Resistance in Patients After Carotid Revascularization

Carotid Stenosis Clinical Trial

Official title:

The Problem of Insulin Resistance in Patients After Carotid Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03419767
• Other study ID #: ZS-1468
• Status: Recruiting
• Phase: Phase 4
• First received: January 27, 2018
• Last updated: January 27, 2018
• Start date: August 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: January 2018
• Source: Peking Union Medical College Hospital
• Contact: Changwei Liu, MD
• Phone: 69152500
• Email: liucw[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to study the phenomenon of insulin resistance in patients after carotid revascularization surgery through population-based, randomized, double-blind, placebo-controlled trial.

Description:

Trial Title: Insulin Resistance in Patients After Carotid Revascularization. Protocol:

Investigators recruited eligible Han Chinese participants (aged 40-80) who were diagnosed with carotid stenosis and had indications for carotid revascularization surgery. Participants were excluded if participants had undergone surgical contraindication, or psychiatric disorders, or cancer, or pregnant, or lactating, or taking antipsychotic drugs during perioperative period. Participants were randomly divided into groups of oral melatonin, and blank control. Participants in groups of oral melatonin took melatonin orally 6mg/day from 3 days before operation to 3 days after operation. Blood samples (about 6 milliliter) were taken at baseline, the first, the second, and the third morning after the operation, all in the fasting state. Through a series hospital clinical laboratory and related ELISA kits to detect the insulin, C-peptide and glucose in serum. Superoxide dismutase (SOD), malonaldehyde (MDA), catalase(CAT), endothelial nitric oxide synthase (eNOS), Interleukin 6 (IL-6), tumour necrosis factor(TNF-α), were included for analysis to verify whether melatonin have protective effect for inflammation and oxidative stress in patients under carotid revascularization, which might be the mechanism of insulin resistance after surgery. This trial is approved by the Ethics Committee of Peking Union Medical College Hospital (No. ZS-1468). All participants completed a questionnaire and signed an informed consent document. Otherwise, participants will get appropriate economic compensation. Trial associates monitored compliance with the masking procedure throughout the trial. All participants and study investigators were unaware of treatment allocation throughout the study. The randomization codes remained sealed until after data collection and cleaning, and completion of a masked analysis. The study team monitored and classified protocol deviations. Investigators summarized baseline clinical and demographic characteristics with descriptive statistics and then determined by the Univariate Analysis of Variance. All the data analyses were done using statistical software SPSS 20.0.

Expected results: Postoperative levels of insulin resistance in both groups are higher than the preoperative. Compared with the blank control group, patients taking melatonin might have lower postoperative levels of insulin resistance, inflammation and oxidative stress.

Consent document: The potential risk, research as a treatment drug of melatonin may delay the metabolism of antipsychotic antipsychotic drug, so when investigators recruit psychiatric disorders or taking antipsychotic drugs orally during the 2 weeks of the trial should exclusion. As a Health care medicine, Melatonin is not suitable for children, so investigators selected recruiting participants under the age of 40 to 80.

The measure to minimize the risk, fully inform the participants and their families the trial's advantages, disadvantages and desired effect. All participants totally agree with the subjects. In this process, at least three or more effective way to get contact with the medical staff or doctor and ensure that those unexpected accident should deserve effective tackle. Participants guarantee to comply with the criterion before start of the trial. Our research involves the application of melatonin is through the china food and drug administration (CFDA) approved to ensure its safety (include its chemical composition, structure, content parameters, main raw material and appropriate crowd). All staff is qualified medical professionals to guarantee the safety of all participants.

The potential risks or discomfort, or inconvenience, or benefits for participants: So far, effective of melatonin in human include regulating sleep, anti-tumor, immune regulation, regulating of inflammation and immune and regulating blood lipid metabolism is confirmed. Adverse reactions is the delay of antipsychotic drug metabolism (so nearly one month ago and during period of the trial participants should not taking antipsychotic drugs) during the trial. The basic principle during the trial is ensure safety of participants.

The relevant content consultation: Everyone have the right to consultation the research content through telephone: +86 01069152500 (principal investigator) and +86 01069155817(Ethics committee).

The rights of withdrew from the trial: Participate in the trial is completely voluntary. If for any reason, participants not willing to participate in, or do not wish to continue to participate in this trial, will not affect the rights and interests of participants. In addition, participants have the right to withdraw this trial at any time. If participants do not accord to the doctor instructions, or for the sake of patients' health and benefits, the doctor or the researchers may also require participants to quit the trial.

The compensation of research: If the participants have any unexpected accident relation with the trial, the compensation and responsibility will be provided by Peking Union Medical College Hospital.

Privacy protection: The privacy of every participant will be protected. The results of the trial in academic publications will not leak any information to identify your personal identity. Peking Union Medical College Hospital will save everybody's data and guarantee not leak without authorization.

Investigators declare no competing interests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed with carotid stenosis

• had indications for carotid revascularization

Exclusion Criteria:

• surgical contraindication

• cardiovascular disease

• psychiatric disorders

• cancer

• pregnant

• lactating

• taking antipsychotic drugs during perioperative period

• history of trauma during perioperative period

Related Conditions & MeSH terms

• Carotid Stenosis
• Insulin Resistance

Intervention

Drug:
• Melatonin
Patients under carotid revascularization surgery taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.

Other:
• blank
Patients under carotid revascularization surgery without taking melatonin

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

de Luis D, Izaola O, de la Fuente B, Aller R. Effect of L-arginine supplementation on insulin resistance and adipocitokines levels in head and neck cancer non diabetic patients after surgery. Nutr Hosp. 2014 Oct 10;30(4):870-5. doi: 10.3305/nh.2014.30.4.7864. — View Citation

Jovanovski-Srceva M, Kuzmanovska B, Mojsova M, Kartalov A, Shosholcheva M, Temelkovska-Stevanoska M, Gavrilovska A, Stavridis S, Spirovski Z, Kondov B, Kokareva A, Todorov R, Spirovska T. Insulin Resistance, Glycemia and Cortisol Levels in Surgical Patients who Had Preoperative Caloric Load with Amino Acids. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):61-70. doi: 10.1515/prilozi-2015-0079. — View Citation

Keane KN, Cruzat VF, Carlessi R, de Bittencourt PI Jr, Newsholme P. Molecular Events Linking Oxidative Stress and Inflammation to Insulin Resistance and ß-Cell Dysfunction. Oxid Med Cell Longev. 2015;2015:181643. doi: 10.1155/2015/181643. Epub 2015 Jul 14. Review. — View Citation

Kücükakin B, Gögenur I, Reiter RJ, Rosenberg J. Oxidative stress in relation to surgery: is there a role for the antioxidant melatonin? J Surg Res. 2009 Apr;152(2):338-47. doi: 10.1016/j.jss.2007.12.753. Epub 2008 Jan 10. Review. — View Citation

Kücükakin B, Lykkesfeldt J, Nielsen HJ, Reiter RJ, Rosenberg J, Gögenur I. Utility of melatonin to treat surgical stress after major vascular surgery--a safety study. J Pineal Res. 2008 May;44(4):426-31. doi: 10.1111/j.1600-079X.2007.00545.x. Epub 2008 Jan 15. — View Citation

Ljungqvist O. Jonathan E. Rhoads lecture 2011: Insulin resistance and enhanced recovery after surgery. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):389-98. doi: 10.1177/0148607112445580. Epub 2012 May 10. Review. — View Citation

Singh M, Chaudhary M, Vashistha A, Kaur G. Evaluation of effects of a preoperative 2-hour fast with glutamine and carbohydrate rich drink on insulin resistance in maxillofacial surgery. J Oral Biol Craniofac Res. 2015 Jan-Apr;5(1):34-9. doi: 10.1016/j.jobcr.2015.02.006. Epub 2015 Mar 4. — View Citation

Tangvarasittichai S. Oxidative stress, insulin resistance, dyslipidemia and type 2 diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):456-80. doi: 10.4239/wjd.v6.i3.456. Review. — View Citation

Thorell A, Nygren J, Ljungqvist O. Insulin resistance: a marker of surgical stress. Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):69-78. Review. — View Citation

van Stijn MFM, Soeters MR, van Leeuwen PAM, Schreurs WH, Schoorl MG, Twisk JWR, De Bandt JP, Bonnefont-Rousselot D, Cynober L, Ackermans MT, Serlie MJ, Houdijk APJ. Effects of a Carbohydrate-, Glutamine-, and Antioxidant-Enriched Oral Nutrition Supplement on Major Surgery-Induced Insulin Resistance: A Randomized Pilot Study. JPEN J Parenter Enteral Nutr. 2017 May 1:148607117711691. doi: 10.1177/0148607117711691. [Epub ahead of print] — View Citation

Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963. — View Citation

Zareba K, Kamocki Z, Kuklinski A, Kedra B. Problem of the insulin resistance in surgery. Pol Przegl Chir. 2011 May;83(5):287-91. doi: 10.2478/v10035-011-0045-1. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance in patients under carotid revascularization assessed by the concentration of insulin	perioperative insulin resistance detected by the concentration of insulin by ELISA kit	3 months
Primary	inflammation in patients under carotid revascularization assessed by the concentration of IL-6	inflammation detected by the concentration of IL-6 by ELISA kit	3 months
Primary	inflammation in patients under carotid revascularization assessed by the concentration of TNF-a	inflammation detected by the concentration of TNF-a by ELISA kit	3 months
Primary	inflammation in patients under carotid revascularization assessed by the concentration of eNOS	inflammation detected by the concentration of eNOS by ELISA kit	3 months
Primary	oxidative stress in patients under carotid revascularization assessed by the concentration of CAT	oxidative stress detected by the concentration of CAT by ELISA kit	3 months
Primary	oxidative stress in patients under carotid revascularization assessed by the concentration of MDA	oxidative stress detected by the concentration of MDA by ELISA kit	3 months
Primary	oxidative stress in patients under carotid revascularization assessed by the concentration of SOD	oxidative stress detected by the concentration of SOD by ELISA kit	3 months