Insulin Resistance in Patients After Carotid Revascularization

NCT03419767 | Unknown Phase 4

• 1 other identifier: ZS-1468
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Keywords

carotid stenosis; melatonin; insulin resistance; inflammation; carotid revascularization; antioxidants

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• inflammation in patients under carotid revascularization assessed by the concentration of TNF-α

  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

  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

  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

  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

  oxidative stress detected by the concentration of SOD by ELISA kit

  3 months

Study Arms (2)

surgery with melatonin

ACTIVE COMPARATOR

Patients under carotid revascularization surgery with melatonin taken during perioperative period.

Drug: Melatonin

surgery with blank control

SHAM COMPARATOR

Patients under carotid revascularization surgery with nothing unnecessary taken during perioperative period

Other: blank

Interventions

Melatonin DRUG

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

surgery with melatonin

blank OTHER

Patients under carotid revascularization surgery without taking melatonin

surgery with blank control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with carotid stenosis
• had indications for carotid revascularization

You may not qualify if:

• surgical contraindication
• cardiovascular disease
• psychiatric disorders
• cancer
• pregnant
• lactating
• taking antipsychotic drugs during perioperative period
• history of trauma during perioperative period

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 27442397 BACKGROUND

• 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.

  PMID: 25335675 BACKGROUND

• 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. 2018 May;42(4):719-729. doi: 10.1177/0148607117711691. Epub 2017 Dec 20.

  PMID: 28541810 BACKGROUND

• 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.

  PMID: 25853046 BACKGROUND

• 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. doi: 10.1097/00075197-199901000-00012.

  PMID: 10453333 BACKGROUND

• 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.

  PMID: 22577121 BACKGROUND

• 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. No abstract available.

  PMID: 22166483 BACKGROUND

• 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.

  PMID: 20101593 BACKGROUND

• Kucukakin 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.

  PMID: 18262562 BACKGROUND

• Kucukakin 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.

  PMID: 18205732 BACKGROUND

• 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.

  PMID: 25897356 BACKGROUND

• Keane 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.

  PMID: 26257839 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Insulin Resistance; Inflammation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Changwei Liu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changwei Liu, MD

CONTACT

69152500; liucw@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 5, 2018
• Study Start: August 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

CN (1)