Carotid StenosisPhase 4NCT03419767
Insulin Resistance in Patients After Carotid Revascularization
A Phase 4 study testing Melatonin and blank in people with Carotid Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Melatonin and blank
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with carotid stenosis
- had indications for carotid revascularization
Who cannot join
- surgical contraindication
- cardiovascular disease
- psychiatric disorders
- cancer
- pregnant
- lactating
- taking antipsychotic drugs during perioperative period
- history of trauma during perioperative period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Changwei Liu, MD, 69152500, liucw@vip.sina.com
Changwei Liu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- Melatonin, blank
- Keywords
- carotid stenosis, melatonin, insulin resistance, inflammation, carotid revascularization, antioxidants
- Medical subject headings
- Carotid Stenosis, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Patients under carotid revascularization surgery taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
blankOther
Patients under carotid revascularization surgery without taking melatonin
| Study group | Role | What they receive |
|---|---|---|
| surgery with melatonin | Active comparator | Patients under carotid revascularization surgery with melatonin taken during perioperative period. Receives: Drug: Melatonin |
| surgery with blank control | Sham comparator | Patients under carotid revascularization surgery with nothing unnecessary taken during perioperative period Receives: Other: blank |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
inflammation in patients under carotid revascularization assessed by the concentration of IL-6
inflammation detected by the concentration of IL-6 by ELISA kit
Measured: 3 months
inflammation in patients under carotid revascularization assessed by the concentration of TNF-α
inflammation detected by the concentration of TNF-α by ELISA kit
Measured: 3 months
inflammation in patients under carotid revascularization assessed by the concentration of eNOS
inflammation detected by the concentration of eNOS by ELISA kit
Measured: 3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of CAT
oxidative stress detected by the concentration of CAT by ELISA kit
Measured: 3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of MDA
oxidative stress detected by the concentration of MDA by ELISA kit
Measured: 3 months
oxidative stress in patients under carotid revascularization assessed by the concentration of SOD
oxidative stress detected by the concentration of SOD by ELISA kit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Aug 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changwei Liu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419767
- Sponsor's protocol ID
- ZS-1468
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27442397de 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.
PubMed 25335675van 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. 2018 May;42(4):719-729. doi: 10.1177/0148607117711691. Epub 2017 Dec 20.
PubMed 28541810Singh 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.
PubMed 25853046Thorell A, Nygren J, Ljungqvist O. Insulin resistance: a marker of surgical stress. Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):69-78. doi: 10.1097/00075197-199901000-00012.
PubMed 10453333Ljungqvist 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.
PubMed 22577121Zareba 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. No abstract available.
PubMed 22166483Wang 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.
PubMed 20101593Kucukakin B, Gogenur 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.
PubMed 18262562Kucukakin B, Lykkesfeldt J, Nielsen HJ, Reiter RJ, Rosenberg J, Gogenur 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.
PubMed 18205732Tangvarasittichai 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.
PubMed 25897356Keane KN, Cruzat VF, Carlessi R, de Bittencourt PI Jr, Newsholme P. Molecular Events Linking Oxidative Stress and Inflammation to Insulin Resistance and beta-Cell Dysfunction. Oxid Med Cell Longev. 2015;2015:181643. doi: 10.1155/2015/181643. Epub 2015 Jul 14.
PubMed 26257839
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Problem of Insulin Resistance in Patients After Carotid Revascularization
- ClinicalTrials.gov ID
- NCT03419767
- Acronym / sponsor ID
- ZS-1468
- Conditions
- Carotid Stenosis
- Keywords
- carotid stenosis, melatonin, insulin resistance, inflammation, carotid revascularization, antioxidants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery with melatonin | Active comparator | Drug: MelatoninPatients under carotid revascularization surgery with melatonin taken during perioperative period. |
| surgery with blank control | Sham comparator | Other: blankPatients under carotid revascularization surgery with nothing unnecessary taken during perioperative period |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with carotid stenosis
- had indications for carotid revascularization
Key exclusion criteria (8 listed)
- surgical contraindication
- cardiovascular disease
- psychiatric disorders
- cancer
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninPatients under carotid revascularization surgery taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation. | Drug | surgery with melatonin |
| blankPatients under carotid revascularization surgery without taking melatonin | Other | surgery with blank control |
Primary outcome
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 27442397Jovanovski-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.
- Background: PubMed 25335675de 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.
- Background: PubMed 28541810van 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. 2018 May;42(4):719-729. doi: 10.1177/0148607117711691. Epub 2017 Dec 20.
- Background: PubMed 25853046Singh 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.
- Background: PubMed 10453333Thorell A, Nygren J, Ljungqvist O. Insulin resistance: a marker of surgical stress. Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):69-78. doi: 10.1097/00075197-199901000-00012.
- Background: PubMed 22577121Ljungqvist 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.
- Background: PubMed 22166483Zareba 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. No abstract available.
- Background: PubMed 20101593Wang 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.
- Background: PubMed 18262562Kucukakin B, Gogenur 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.
- Background: PubMed 18205732Kucukakin B, Lykkesfeldt J, Nielsen HJ, Reiter RJ, Rosenberg J, Gogenur 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.
- Background: PubMed 25897356Tangvarasittichai 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.
- Background: PubMed 26257839Keane KN, Cruzat VF, Carlessi R, de Bittencourt PI Jr, Newsholme P. Molecular Events Linking Oxidative Stress and Inflammation to Insulin Resistance and beta-Cell Dysfunction. Oxid Med Cell Longev. 2015;2015:181643. doi: 10.1155/2015/181643. Epub 2015 Jul 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changwei Liu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and blank in people with Carotid Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changwei Liu, MD (69152500, liucw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance in patients under carotid revascularization assessed by the concentration of insulin (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419767, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.