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Insulin Resistance in Patients After Carotid Revascularization

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ClinicalTrials.gov Identifier: NCT03419767
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Melatonin Other: blank Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Problem of Insulin Resistance in Patients After Carotid Revascularization
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419767


Contacts
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Contact: Changwei Liu, MD 69152500 liucw@vip.sina.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Changwei Liu, MD    69152500    liucw@vip.sina.com   
Principal Investigator: Changwei Liu, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Changwei Liu, MD Peking Union Medical College Hospital

Publications:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03419767     History of Changes
Other Study ID Numbers: ZS-1468
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
carotid stenosis
melatonin
insulin resistance
inflammation
carotid revascularization
antioxidants

Additional relevant MeSH terms:
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Insulin Resistance
Carotid Stenosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin
Melatonin
Hypoglycemic Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants