Insulin Resistance in Patients After Carotid Revascularization
Insulin Resistance in Patients After Carotid Revascularization
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.
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.
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