Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus

NCT04259606 | Unknown DMC

• 1 other identifier: CCRA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus is considered a serious public health problem that has been raising worldwide. In Mexico, it is an important cause of morbi - mortality and it´s characterized by hyperglycemia that promotes an increase of cardiovascular risk through the impairment of arterial stiffness and endothelial function, which, in a chronic manner promotes the development of micro and macrovascular complications. Many nutraceuticals have been currently implemented aimed to improve glycemic control, and reduce cardiovascular risk and it´s complications, which results in a better quality of life in patients with type 2 diabetes mellitus. Cassia cinnamon pulverized bark has demonstrated to have vasodilator effect independent of endothelial mechanisms, probably regulating calcium influx or release into or within the cell, the later demonstrated in mice.

Conditions

Arterial Stiffness

Keywords

Cassia cinnamon; Endothelial function; Pulse wave velocity; Brachial - ankle index

Outcome Measures

Primary Outcomes (3)

• Brachial - ankle pulse wave velocity

  Change in the pulse wave velocity

  90 days

• Flow mediated dilation

  Change in the capacity of dilation of the brachial artery

  90 days

• Brachial - ankle index

  Change in the systolic and diastolic pressures of the brachial and tibial arteries, the index is the result of dividing the last between the first

  90 days

Secondary Outcomes (4)

• Systolic and diastolic blood pressure

  4 visits: days 1, 30, 60 and 90.

• Blood glucose

  4 visits: days 1, 30, 60 and 90.

• Glycated hemoglobin

  4 visits: days 1, 30, 60 and 90.

• Lipid profile

  4 visits: days 1, 30, 60 and 90.

Study Arms (2)

Cassia Cinnamon

ACTIVE COMPARATOR

Cassia cinnamon, capsule of 1 gram each, taken every 8 hours before meals for 90 days.

Dietary Supplement: Cassia Cinnamon

Calcined Magnesia

PLACEBO COMPARATOR

Placebo consists in calcined magnesia, capsule of 1 gram each, taken every 8 hours before meals for 90 days.

Other: Calcined magnesia

Interventions

Cassia Cinnamon DIETARY_SUPPLEMENT

Reddish - brown to light brown, typical sweet and aromatic free flowing powder.

Cassia Cinnamon

Calcined magnesia OTHER

White, odor, color and flavorless thin powder.

Calcined Magnesia

Eligibility Criteria

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

You may qualify if:

• Written informed consent prior to the beginning of enrollment
• Men and women 40 to 65 years old
• Diagnosis of type 2 diabetes mellitus according to the American Diabetes Association criteria
• Fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L) at least 8 h of fasting
• Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) 2 hours after oral glucose tolerance test
• HbA1c ≥ 6.5 % (48 mmol/mol)
• Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) in a random glucose test with typical symptoms of hyperglucemia or hyperglycemic crisis.

You may not qualify if:

• HbA1c \< 6.5 % or \> 10 % or fasting glucose plasma \> 250 mg/dl
• Total serum cholesterol ≥ 240 mg/dl
• Triglycerides ≥ 400 mg/dl
• History of allergy to any of the components used in the study
• Consumption of additional drugs with known effects on glucose and lipids metabolism and weight reduction
• History of cardiovascular disease, blood abnormalities and/or kidney, pancreatic or thyroid disease
• Childbearing and breastfeeding women
• History of smoking within 12 months prior to beginning of study
• History of drug abuse and alcoholism
• Pacemaker bearing or any other permanent bioelectronic device that could modify or interfere with electrical bioimpedance tests

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

Related Publications (57)

• American Diabetes Association. Standards of Medical Care in Diabetes-2019 Abridged for Primary Care Providers. Clin Diabetes. 2019 Jan;37(1):11-34. doi: 10.2337/cd18-0105. No abstract available.

  PMID: 30705493 BACKGROUND

• Rosas Y, Calles J. Documento de posición de la Asociación Latinoamericana de Diabetes (ALAD). Consenso de prediabetes. 2009;17:146-158

  BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.

  PMID: 22922414 BACKGROUND

• Arauz A, Ruíz-Franco A. Enfermedad Vascular Cerebral. Rev Fac Medicina UNAM.2012;55:11-21

  BACKGROUND

• Ritz E. Nephropathy in type 2 diabetes. J Intern Med. 1999 Feb;245(2):111-26. doi: 10.1046/j.1365-2796.1999.00411.x.

  PMID: 10081514 BACKGROUND

• Javed S, Alam U, Malik RA. Treating Diabetic Neuropathy: Present Strategies and Emerging Solutions. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):63-83. doi: 10.1900/RDS.2015.12.63. Epub 2015 Aug 10.

  PMID: 26676662 BACKGROUND

• Pedraza L. Neuropatías diabéticas, formas clínicas y diagnóstico. Rev Med Clin.2009;20:681-686

  BACKGROUND

• Julio R, Galleguillos I. Diabetes y enfermedad vascular periférica. Rev Med Clin. 2009;20:687-697

  BACKGROUND

• Cervantes R, Presno J. Fisiopatología de la diabetes y los mecanismos de muerte de las células β pancreáticas. Rev. Endocrinol. Nutr.2013;21:98-106

  BACKGROUND

• Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.

  PMID: 25538310 BACKGROUND

• DeFronzo RA, Abdul-Ghani M. Type 2 diabetes can be prevented with early pharmacological intervention. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S202-9. doi: 10.2337/dc11-s221.

  PMID: 21525456 BACKGROUND

• de Oliveira Alvim R, Santos PCJL, Musso MM, de Sa Cunha R, Krieger JE, Mill JG, Pereira AC. Impact of diabetes mellitus on arterial stiffness in a representative sample of an urban Brazilian population. Diabetol Metab Syndr. 2013 Aug 21;5(1):45. doi: 10.1186/1758-5996-5-45.

  PMID: 23965633 BACKGROUND

• Jia G, Aroor AR, DeMarco VG, Martinez-Lemus LA, Meininger GA, Sowers JR. Vascular stiffness in insulin resistance and obesity. Front Physiol. 2015 Aug 14;6:231. doi: 10.3389/fphys.2015.00231. eCollection 2015.

  PMID: 26321962 BACKGROUND

• Yeboah K, Antwi DA, Gyan B. Arterial Stiffness in Nonhypertensive Type 2 Diabetes Patients in Ghana. Int J Endocrinol. 2016;2016:6107572. doi: 10.1155/2016/6107572. Epub 2016 Sep 28.

  PMID: 27774104 BACKGROUND

• Li X, Deng YP, Yang M, Wu YW, Sun SX, Sun JZ. Low-Grade Inflammation and Increased Arterial Stiffness in Chinese Youth and Adolescents with Newly-Diagnosed Type 2 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):268-73. doi: 10.4274/jcrpe.2187.

  PMID: 26777037 BACKGROUND

• Morales S, Garcia-Salcedo JA, Munoz-Torres M. [Pentosidine: a new biomarker in diabetes mellitus complications]. Med Clin (Barc). 2011 Mar 19;136(7):298-302. doi: 10.1016/j.medcli.2009.12.001. Epub 2010 Mar 11. Spanish.

  PMID: 20226481 BACKGROUND

• Cardoso CR, Salles GF. Aortic Stiffness as a Surrogate Endpoint to Micro- and Macrovascular Complications in Patients with Type 2 Diabetes. Int J Mol Sci. 2016 Dec 6;17(12):2044. doi: 10.3390/ijms17122044.

  PMID: 27929441 BACKGROUND

• Weisbrod RM, Shiang T, Al Sayah L, Fry JL, Bajpai S, Reinhart-King CA, Lob HE, Santhanam L, Mitchell G, Cohen RA, Seta F. Arterial stiffening precedes systolic hypertension in diet-induced obesity. Hypertension. 2013 Dec;62(6):1105-10. doi: 10.1161/HYPERTENSIONAHA.113.01744. Epub 2013 Sep 23.

  PMID: 24060894 BACKGROUND

• Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.

  PMID: 26160955 BACKGROUND

• Suarez C, Ruilope LM. [New guidelines from the World Health Organization and the International Society of Hypertension for the management of hypertension: toward common guidelines]. Rev Esp Cardiol. 1999 Jun;52(6):381-2. doi: 10.1016/s0300-8932(99)74934-1. No abstract available. Spanish.

  PMID: 10373770 BACKGROUND

• Medagama AB, Bandara R. The use of complementary and alternative medicines (CAMs) in the treatment of diabetes mellitus: is continued use safe and effective? Nutr J. 2014 Oct 21;13:102. doi: 10.1186/1475-2891-13-102.

  PMID: 25331834 BACKGROUND

• Chang CT, Chang WL, Hsu JC, Shih Y, Chou ST. Chemical composition and tyrosinase inhibitory activity of Cinnamomum cassia essential oil. Bot Stud. 2013 Dec;54(1):10. doi: 10.1186/1999-3110-54-10. Epub 2013 Aug 21.

  PMID: 28510850 BACKGROUND

• Rao PV, Gan SH. Cinnamon: a multifaceted medicinal plant. Evid Based Complement Alternat Med. 2014;2014:642942. doi: 10.1155/2014/642942. Epub 2014 Apr 10.

  PMID: 24817901 BACKGROUND

• Vangalapati M, Satya S, Prakash S, Avanigadda S. A review on pharmacological activities and clinical effects of Cinnamon species. J Pharm Biol Chem Sci. 2012;3(1):653-663

  BACKGROUND

• Akilen R, Tsiami A, Devendra D, Robinson N. Glycated haemoglobin and blood pressure-lowering effect of cinnamon in multi-ethnic Type 2 diabetic patients in the UK: a randomized, placebo-controlled, double-blind clinical trial. Diabet Med. 2010 Oct;27(10):1159-67. doi: 10.1111/j.1464-5491.2010.03079.x.

  PMID: 20854384 BACKGROUND

• Xue YL, Shi HX, Murad F, Bian K. Vasodilatory effects of cinnamaldehyde and its mechanism of action in the rat aorta. Vasc Health Risk Manag. 2011;7:273-80. doi: 10.2147/VHRM.S15429. Epub 2011 Apr 28.

  PMID: 21603596 BACKGROUND

• Kang YH, Yang IJ, Morgan KG, Shin HM. Cinnamyl alcohol attenuates vasoconstriction by activation of K(+) channels via NO-cGMP-protein kinase G pathway and inhibition of Rho-kinase. Exp Mol Med. 2012 Dec 31;44(12):749-55. doi: 10.3858/emm.2012.44.12.083.

  PMID: 23178275 BACKGROUND

• Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003 Dec;26(12):3215-8. doi: 10.2337/diacare.26.12.3215.

  PMID: 14633804 BACKGROUND

• Ziegenfuss TN, Hofheins JE, Mendel RW, Landis J, Anderson RA. Effects of a water-soluble cinnamon extract on body composition and features of the metabolic syndrome in pre-diabetic men and women. J Int Soc Sports Nutr. 2006 Dec 28;3(2):45-53. doi: 10.1186/1550-2783-3-2-45.

  PMID: 18500972 BACKGROUND

• Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.

  PMID: 2753525 BACKGROUND

• Zócalo Y, Bia D. Presión aórtica central y parámetros clínicos derivados de la onda del pulso: evaluación no invasiva en la práctica clínica. Rev Urug Cardiol. 2014;29:215-230

  BACKGROUND

• Gomez Marcos MA, Recio Rodriguez JI, Rodriguez Sanchez E, Patino Alonso MC, Gomez Sanchez L, Garcia ortiz L. [The increase in the speed of the pulse wave is not associated with elevated central blood pressure in hypertensive patients with kidney disease]. Nefrologia. 2010;30(5):578-83. doi: 10.3265/Nefrologia.pre2010.June.10383. Spanish.

  PMID: 20613849 BACKGROUND

• Calabia Martínez, J. Medida de la Velocidad de Onda de Pulso mediante Ecografía Doppler: Concordancia con el Método Complior.2016

  BACKGROUND

• Sáez J. Distensibilidad arterial: un parámetro más para valorar el riesgo cardiovascular. SEMERGEN. 2008;34(6):284-90

  BACKGROUND

• Polo C, Del Castillo M. El índice cintura-cadera. Revisión. Madrid: Centro de Medicina Deportiva, Comunidad de Madrid

  BACKGROUND

• Compendio de Leyes y Reglamentos. Agenda de Salud 2002. Tercera edición. México: Ediciones fiscals ISEF, 2002

  BACKGROUND

• Rabkin SW, Chan SH, Sweeney C. Ankle-brachial index as an indicator of arterial stiffness in patients without peripheral artery disease. Angiology. 2012 Feb;63(2):150-4. doi: 10.1177/0003319711410307. Epub 2011 Jun 15.

  PMID: 21676966 BACKGROUND

• Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.

  PMID: 11788217 BACKGROUND

• Mozos I, Malainer C, Horbanczuk J, Gug C, Stoian D, Luca CT, Atanasov AG. Inflammatory Markers for Arterial Stiffness in Cardiovascular Diseases. Front Immunol. 2017 Aug 31;8:1058. doi: 10.3389/fimmu.2017.01058. eCollection 2017.

  PMID: 28912780 BACKGROUND

• Hamilton SJ, Watts GF. Endothelial dysfunction in diabetes: pathogenesis, significance, and treatment. Rev Diabet Stud. 2013 Summer-Fall;10(2-3):133-56. doi: 10.1900/RDS.2013.10.133. Epub 2013 Aug 10.

  PMID: 24380089 BACKGROUND

• Bia D, Zócalo Y. Rigidez arterial: evaluación no invasiva en la práctica clínica. Rev Urug Cardiol. 2014;29:39-59

  BACKGROUND

• Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.

  PMID: 20530030 BACKGROUND

• Christen A, Miranda A, Caride S, Armentano R, Ramírez A, Sánchez R. Velocidad de la onda de pulso: relevancia de la edad en normotensión, hipertensión escencial e hipertensión limítrofe. Rev. Argent. Cardiol. 2015;83:112-118

  BACKGROUND

• Sánchez-Martínez M, Cruz J, Graciani A, García E, Artalejo F, Banegas J. Velocidad de la onda de pulso y presión arterial central: valores normales y de referencia en personas mayores en España. Rev Esp Cardiol. 2018:1-3

  BACKGROUND

• Zhu R, Liu H, Liu C, Wang L, Ma R, Chen B, Li L, Niu J, Fu M, Zhang D, Gao S. Cinnamaldehyde in diabetes: A review of pharmacology, pharmacokinetics and safety. Pharmacol Res. 2017 Aug;122:78-89. doi: 10.1016/j.phrs.2017.05.019. Epub 2017 May 27.

  PMID: 28559210 BACKGROUND

• Hajimonfarednejad M, Ostovar M, Raee MJ, Hashempur MH, Mayer JG, Heydari M. Cinnamon: A systematic review of adverse events. Clin Nutr. 2019 Apr;38(2):594-602. doi: 10.1016/j.clnu.2018.03.013. Epub 2018 Apr 5.

  PMID: 29661513 BACKGROUND

• Diabetes, O. M. S. Informe Mundial sobre la Diabetes. Ginebra. 2016

  BACKGROUND

• Instituto Nacional de Estadística y Geografía. Principales causas de mortalidad por residencia habitual, grupos de edad y sexo del fallecido. 2016

  BACKGROUND

• International Diabetes Federation. IDF Diabetes Atlas. 8ª edición. 2017

  BACKGROUND

• Romero-Martinez M, Shamah-Levy T, Cuevas-Nasu L, Gomez-Humaran IM, Gaona-Pineda EB, Gomez-Acosta LM, Rivera-Dommarco JA, Hernandez-Avila M. [Methodological design of the National Health and Nutrition Survey 2016]. Salud Publica Mex. 2017 May-Jun;59(3):299-305. doi: 10.21149/8593. Spanish.

  PMID: 28902317 BACKGROUND

• National Institute for Healt and Care Excellence. Type 2 diabetes: prevention in people at high risk. Pub. Health Guidel. 2012

  BACKGROUND

• Prevención secundaria, diagnóstico, tratamiento y vigilancia de la enfermedad cerebral isquémica. México Secretaría de Salud. 2008

  BACKGROUND

• Martinez-Murillo C, Aguilar-Arteaga ML, Velasco-Ortega E, Alonso-Gonzalez R, Castellanos-Sinco H, Romo-Jimenez A, Vargas-Ruiz A, Torres-Arreola L, Viniegra-Osorio A. [Clinical guideline for diagnosis and treatment of the thromboembolic venous disease]. Rev Med Inst Mex Seguro Soc. 2011 Jul-Aug;49(4):437-49. Spanish.

  PMID: 21982196 BACKGROUND

• Millan-Gamez YK, Wacher-Rodarte NH, Bravo-Ortiz JC, Garrido-Gaspar NH, Mendoza-Topete R, Martinez-Ruiz AM, Miller-Arrevillaga G, Ramirez-Najera A. [Clinical practice guidelines. Diagnosis and treatment of diabetic retinopathy]. Rev Med Inst Mex Seguro Soc. 2011 Sep-Oct;49(5):551-62. Spanish.

  PMID: 22185860 BACKGROUND

• Harrison´s Principles of Internal Medicine (2015). Kasper D, Hauser S, Jameson J. McGrawHill

  BACKGROUND

• Herbs & natural supplements an evidence-based guide. 2010. Braun L, Cohen M. ELSEVIER

  BACKGROUND

• Delgadillo-Centeno JS, Grover-Paez F, Hernandez-Gonzalez SO, Ramos-Zavala MG, Cardona-Muller D, Lopez-Castro A, Pascoe-Gonzalez S. Cinnamomum cassia on Arterial Stiffness and Endothelial Dysfunction in Type 2 Diabetes Mellitus: Outcomes of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Med Food. 2023 Jun;26(6):428-434. doi: 10.1089/jmf.2022.0089. Epub 2023 Jun 1.

  PMID: 37262194 DERIVED

Related Links

• Chemical properties of bark cinnamon derived Cinnamaldehyde

Study Officials

• Sandra Ofelia Hernández González, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Pascoe González, PhD

CONTACT

3331370639; spg0371@gmail.com

María G Ramos Zavala, PhD

CONTACT

3339523367; ramos.zavala.mg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel, randomized, double blind, with control group. The study consists in two groups assigned to take either cassia cinnamon or placebo. Both groups will be taken Metformin as first line therapy for type 2 diabetes mellitus

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: February 6, 2020
• Study Start: August 17, 2018
• Primary Completion: January 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

ME (1)