Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
NCT ID: NCT04532385
Last Updated: 2020-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-06-12
2019-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GTE
Green tea extract, 400 mg every 12 hours for 12 weeks
Green tea extract
400 mg capsule
Placebo
Calcined magnesia, 400 mg every 12 hours for 12 weeks
Placebo
400 mg capsule
Interventions
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Green tea extract
400 mg capsule
Placebo
400 mg capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Smoking patients
* Ischemic heart disease
* Use of anti-inflammatory or antioxidant drugs
* Previously diagnosed liver or thyroid disease
40 Years
65 Years
ALL
No
Sponsors
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Centro Universitario de Ciencias de la Salud, Mexico
OTHER
Responsible Party
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Fernando Grover Paez
Profesor Investigador Titular A
Locations
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Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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References
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Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
Gavish B, Izzo JL Jr. Arterial Stiffness: Going a Step Beyond. Am J Hypertens. 2016 Nov 1;29(11):1223-1233. doi: 10.1093/ajh/hpw061.
Shirwany NA, Zou MH. Arterial stiffness: a brief review. Acta Pharmacol Sin. 2010 Oct;31(10):1267-76. doi: 10.1038/aps.2010.123. Epub 2010 Aug 30.
Lessiani G, Santilli F, Boccatonda A, Iodice P, Liani R, Tripaldi R, Saggini R, Davi G. Arterial stiffness and sedentary lifestyle: Role of oxidative stress. Vascul Pharmacol. 2016 Apr;79:1-5. doi: 10.1016/j.vph.2015.05.017. Epub 2015 Jun 2.
Virdis A, Taddei S. Endothelial Dysfunction in Resistance Arteries of Hypertensive Humans: Old and New Conspirators. J Cardiovasc Pharmacol. 2016 Jun;67(6):451-7. doi: 10.1097/FJC.0000000000000362.
de Maat MP, Pijl H, Kluft C, Princen HM. Consumption of black and green tea had no effect on inflammation, haemostasis and endothelial markers in smoking healthy individuals. Eur J Clin Nutr. 2000 Oct;54(10):757-63. doi: 10.1038/sj.ejcn.1601084.
Stokes GS, Barin ES, Gilfillan KL. Effects of isosorbide mononitrate and AII inhibition on pulse wave reflection in hypertension. Hypertension. 2003 Feb;41(2):297-301. doi: 10.1161/01.hyp.0000049622.07021.4f.
Vlachopoulos C, Terentes-Printzios D, Ioakeimidis N, Rokkas K, Samentzas A, Aggelis A, Kardara D, Stefanadis C. Beneficial effect of vardenafil on aortic stiffness and wave reflections. J Clin Pharmacol. 2012 Aug;52(8):1215-21. doi: 10.1177/0091270011413586. Epub 2011 Sep 27.
Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.
Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
Kohara K, Tabara Y, Oshiumi A, Miyawaki Y, Kobayashi T, Miki T. Radial augmentation index: a useful and easily obtainable parameter for vascular aging. Am J Hypertens. 2005 Jan;18(1 Pt 2):11S-14S. doi: 10.1016/j.amjhyper.2004.10.010.
Cui R, Yamagishi K, Muraki I, Hayama-Terada M, Umesawa M, Imano H, Li Y, Eshak ES, Ohira T, Kiyama M, Okada T, Kitamura A, Tanigawa T, Iso H; CIRCS investigators. Association between markers of arterial stiffness and atrial fibrillation in the Circulatory Risk in Communities Study (CIRCS). Atherosclerosis. 2017 Aug;263:244-248. doi: 10.1016/j.atherosclerosis.2017.06.918. Epub 2017 Jun 22.
Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
Quezada-Fernandez P, Trujillo-Quiros J, Pascoe-Gonzalez S, Trujillo-Rangel WA, Cardona-Muller D, Ramos-Becerra CG, Barocio-Pantoja M, Rodriguez-de la Cerda M, Nerida Sanchez-Rodriguez E, Cardona-Munoz EG, Garcia-Benavides L, Grover-Paez F. Effect of green tea extract on arterial stiffness, lipid profile and sRAGE in patients with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2019 Dec;70(8):977-985. doi: 10.1080/09637486.2019.1589430. Epub 2019 May 14.
Brown AL, Lane J, Coverly J, Stocks J, Jackson S, Stephen A, Bluck L, Coward A, Hendrickx H. Effects of dietary supplementation with the green tea polyphenol epigallocatechin-3-gallate on insulin resistance and associated metabolic risk factors: randomized controlled trial. Br J Nutr. 2009 Mar;101(6):886-94. doi: 10.1017/S0007114508047727. Epub 2008 Aug 19.
Onakpoya I, Spencer E, Heneghan C, Thompson M. The effect of green tea on blood pressure and lipid profile: a systematic review and meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2014 Aug;24(8):823-36. doi: 10.1016/j.numecd.2014.01.016. Epub 2014 Jan 31.
Marinovic MP, Morandi AC, Otton R. Green tea catechins alone or in combination alter functional parameters of human neutrophils via suppressing the activation of TLR-4/NFkappaB p65 signal pathway. Toxicol In Vitro. 2015 Oct;29(7):1766-78. doi: 10.1016/j.tiv.2015.07.014. Epub 2015 Jul 15.
Bogdanski P, Suliburska J, Szulinska M, Stepien M, Pupek-Musialik D, Jablecka A. Green tea extract reduces blood pressure, inflammatory biomarkers, and oxidative stress and improves parameters associated with insulin resistance in obese, hypertensive patients. Nutr Res. 2012 Jun;32(6):421-7. doi: 10.1016/j.nutres.2012.05.007. Epub 2012 Jun 20.
Cox AJ, West NP, Cripps AW. Obesity, inflammation, and the gut microbiota. Lancet Diabetes Endocrinol. 2015 Mar;3(3):207-15. doi: 10.1016/S2213-8587(14)70134-2. Epub 2014 Jul 22.
Other Identifiers
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CUCS-INTEC-MV-TEVE-002
Identifier Type: -
Identifier Source: org_study_id