Insulin Resistance in Patients After Carotid Revascularization

January 27, 2018 updated by: Peking Union Medical College Hospital

The Problem of 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: surgery with melatonin
Patients under carotid revascularization surgery with melatonin taken during perioperative period.
Drug: Melatonin
Patients under carotid revascularization surgery taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
SHAM_COMPARATOR: surgery with blank control
Patients under carotid revascularization surgery with nothing unnecessary taken during perioperative period
Other: blank
Patients under carotid revascularization surgery without taking melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance in patients under carotid revascularization assessed by the concentration of insulin
Time Frame: 3 months
perioperative insulin resistance detected by the concentration of insulin by ELISA kit
3 months
inflammation in patients under carotid revascularization assessed by the concentration of IL-6
Time Frame: 3 months
inflammation detected by the concentration of IL-6 by ELISA kit
3 months
inflammation in patients under carotid revascularization assessed by the concentration of TNF-α
Time Frame: 3 months
inflammation detected by the concentration of TNF-α by ELISA kit
3 months
inflammation in patients under carotid revascularization assessed by the concentration of eNOS
Time Frame: 3 months
inflammation detected by the concentration of eNOS by ELISA kit
3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of CAT
Time Frame: 3 months
oxidative stress detected by the concentration of CAT by ELISA kit
3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of MDA
Time Frame: 3 months
oxidative stress detected by the concentration of MDA by ELISA kit
3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of SOD
Time Frame: 3 months
oxidative stress detected by the concentration of SOD by ELISA kit
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

January 27, 2018

First Submitted That Met QC Criteria

January 27, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-1468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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