Clinical trial NCT03906201: Effect of Phytoecdysterone Administration in Subjects With Prediabetes
Official title: Effect of Phytoecdysterone Administration on Cytotoxicity, Genotoxicity and Metabolic Control in Subjects With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Keywords: PreDiabetes
Ecdysterone
Genotoxicity
Citotoxicity
Micronuclei
Glycemic Control
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
Primary purpose: TREATMENT

Brief summary: Prediabetes is the term used for people whose glucose levels do not meet the criteria for diabetes but are too high to be considered normal. This is defined by the presence of blood glucose between 100-125 mg / dL, values per glucose tolerance curve of 140-199mg / dL and/or HbA1c 5.7-6.4%. Prediabetes should not be considered as a clinical entity in itself, but as a risk factor for diabetes and cardiovascular disease (CVD). Prediabetes is associated with obesity (especially abdominal or visceral obesity), dyslipidemia with elevated triglycerides and/or low HDL cholesterol, and hypertension.

Detailed description: Subjects with a diagnosis of prediabetes are included according to the criteria of the American Diabetes Association in its version 2019, between 30 and 60 years old residents of the city of Guadalajara, Jalisco, Mexico who come to clinical nutrition consultation in the University Hospital Fray Antonio Alcalde from the city of Guadalajara, Jalisco, Mexico.

The study design is a randomized, randomized clinical trial with a control group in two groups: an intervention group with ecdysterone 300mg every 24 hours for 12 weeks (approximately 90 days) and an approved placebo control group (magnesia stearate) ) at 300mg every 24 hours for 12 weeks (approximately 90 days).

Eligibility criteria: Inclusion Criteria:

1. - Fasting Plasma Glucose between 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L)
2. - Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
3. - A1C 5.7-6.4% (39-47 mmol/mol).
4. - Body Mass Index \>25 kg/m2 or \>23 kg/m2
5. - Adults who have one or more of the following risk factors:

   * First-degree relative with diabetes
   * High-risk race/ethnicity
   * History of CVD
6. - Blood Pressure \<140/90 mmHg without therapy for hypertension
7. - HDL cholesterol level \<0.35 mg/dL (0.90 mmol/L) and/or a triglyceride level \>0.250 mg/dL (2.82 mmol/L)

Exclusion Criteria:

1.- Pregnant women or lactic period 2- Patients with some other chronic degenerative disease like diabetes mellitus 2 with pharmacologic treatment.

3.- Hypertension 4.- Cancer, 5.- Hyperthyroidism 6.- Hypothyroidism 7.- Immunologic disease 8.- Kidney disease 9.- Hepatic disease 10.- Cardiovascular disease 11- Abaqus activity 12.-Alcoholic activity.

Primary outcomes:
measure: Changes in the number of micronuclei after 90 days
timeFrame: 90 days
measure: Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo
timeFrame: 90 days
measure: Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
timeFrame: 90 days
Secondary outcomes:
measure: Body Weight
timeFrame: 90 days
measure: Body Mass Index
timeFrame: 90 days
measure: Waist Circumference
timeFrame: 90 days
measure: Total Cholesterol
timeFrame: 90 days
measure: Triglycerides levels
timeFrame: 90 days
measure: High Density Lipoprotein (c-HDL) levels
timeFrame: 90 days
measure: Low Density Lipoproteins (c-LDL) levels
timeFrame: 90 days
measure: Creatinine levels
timeFrame: 90 days
measure: Alanine aminotransferase (ALT) levels
timeFrame: 90 days
measure: Aspartate aminotransferase (AST) levels
timeFrame: 90 days
measure: Blood pressure
timeFrame: 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Ana Fletes
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: ANA FLETES
role: PRINCIPAL_INVESTIGATOR
References:
citation: Álvarez-Gasca Ma, Hernández-Pozo MR, Jiménez-Martínez M, Durán-Díaz A. Estilo de vida y presencia de síndrome metabólico en estudiantes universitarios. Diferencias por sexo. Rev de psicología. 2014; 32(1):121-138
citation: Andreassi MG, Barale R, Iozzo P, Picano E. The association of micronucleus frequency with obesity, diabetes and cardiovascular disease. Mutagenesis. 2011 Jan;26(1):77-83. doi: 10.1093/mutage/geq077.
citation: •Aparicio MR, Estrada LA, Fernández C, Hernández RM, Ruiz M, Ramos D, et al. Manual de antropometría. Instituto nacional de ciencias médicas y nutrición salvador zubirán: 2014 citar en:http://www.facmed.unam.mx/deptos/salud/censenanza/spi/unidad2/antropometria_manualinnsz.pdf
citation: Berti C, Riso P, Monti LD, Porrini M. In vitro starch digestibility and in vivo glucose response of gluten-free foods and their gluten counterparts. Eur J Nutr. 2004 Aug;43(4):198-204. doi: 10.1007/s00394-004-0459-1. Epub 2004 Jan 6.
citation: Graf BL, Poulev A, Kuhn P, Grace MH, Lila MA, Raskin I. Quinoa seeds leach phytoecdysteroids and other compounds with anti-diabetic properties. Food Chem. 2014 Nov 15;163:178-85. doi: 10.1016/j.foodchem.2014.04.088. Epub 2014 May 4.
citation: FAO, 2013. Food and agriculture organization of the united nations rome. Http://www.fao.org/docrep/018/i3300e/i3300e00.pdf
citation: FAO. Food and agriculture organization of the united nations 2011. La quinua: cultivo milenario para contribuir a la seguridad alimentaria mundial. Http://www.fao.org/docrep/017/aq287s/aq287s.pdf
citation: Figuerola F, Muñoz O, Estévez AM. La linaza como fuente de compuestos bioactivos para la elaboración de alimentos. Agro sur. 2008; 36(2): 49-58. Doi:10.4206/agrosur.2008.v36n2-01
citation: Gutiérrez JP, Rivera-Dommarco J, Shamah-Levy T, Villalpando-Hernández S, Franco A, Cuevas-Nasu l, et al. Encuesta nacional de salud y nutrición 2012. Resultados nacionales. Cuernavaca, méxico: instituto nacional de salud pública (mx), 2012
citation: Harishankar MK, Logeshwaran S, Sujeevan S, Aruljothi KN, Dannie MA, Devi A. Genotoxicity evaluation of metformin and glimepiride by micronucleus assay in exfoliated urothelial cells of type 2 diabetes mellitus patients. Food Chem Toxicol. 2015 Sep;83:146-50. doi: 10.1016/j.fct.2015.06.013. Epub 2015 Jun 24.
citation: Karaman A, Aydin H, Geckinli B, Cetinkaya A, Karaman S. DNA damage is increased in lymphocytes of patients with metabolic syndrome. Mutat Res Genet Toxicol Environ Mutagen. 2015 Apr;782:30-5. doi: 10.1016/j.mrgentox.2015.03.009. Epub 2015 Mar 13.
citation: Leon-Munoz LM, Guallar-Castillon P, Lopez Garcia E, Banegas JR, Gutierrez-Fisac JL, Rodriguez-Artalejo F. Relationship of BMI, waist circumference, and weight change with use of health services by older adults. Obes Res. 2005 Aug;13(8):1398-404. doi: 10.1038/oby.2005.169.
citation: Lizarzaburu-Robles JC. Síndrome metabólico: metabolicsyndrome: concept and practical application. An facmed. 2013;74(4):315-320.
citation: Kaufer-Horwitz M, Toussaint G. Indicadores antropométricos para evaluar sobrepeso y obesidad en pediatría. Bol. Med. Hosp. Infant. Mex; 2008;65(6): 502-518.
citation: Moreno-Altamirano l, García-García JJ, Soto-Estrada G, Capraro S, Limón-Cruz D. Epidemiología y determinantes sociales asociados a la obesidad y la diabetes tipo 2 en méxico. Revmedhosp gen méx. 2014; 77(3):86-95.
citation: Morris D, Vaisey-Genserb. Availability and labeling of flaxseedfood, products and supplements. In: thompson, l. U.; cunnane s. C. Flaxseed in human nutrition. 2003. 2nd edn., champaign, illinois. Aocs press. Pp. 404-422.
citation: Murakami A, Ashida H, Terao J. Multitargeted cancer prevention by quercetin. Cancer Lett. 2008 Oct 8;269(2):315-25. doi: 10.1016/j.canlet.2008.03.046. Epub 2008 May 7.
citation: Ojeda-Lavin A. Proyecciones de la población 2010-2050. Consejo nacional de población méxico. 2014.http://www.conapo.gob.mx/es/conapo/proyecciones.
citation: Omsa. Datos y cifras. 10 datos sobre la obesidad. 2015. Disponible en: http://www.who.int/features/factfiles/obesity/facts/es/index1.html
citation: Cuevas ZO, Sangronis E. [Characterization of flaxseed (Linum usitatissimum L.) grown in Venezuela]. Arch Latinoam Nutr. 2012 Jun;62(2):192-200. Spanish.
citation: Penarrieta JM, Alvarado JA, Akesson B, Bergenstahl B. Total antioxidant capacity and content of flavonoids and other phenolic compounds in canihua (Chenopodium pallidicaule): an Andean pseudocereal. Mol Nutr Food Res. 2008 Jun;52(6):708-17. doi: 10.1002/mnfr.200700189.
citation: Rajesha J, Murthy KN, Kumar MK, Madhusudhan B, Ravishankar GA. Antioxidant potentials of flaxseed by in vivo model. J Agric Food Chem. 2006 May 31;54(11):3794-9. doi: 10.1021/jf053048a.
citation: Ramcharitar A, Badrie N, Mattfeldtbeman M, Matsuo H, Ridley C. Consumeracceptability of muffinswithflaxseed (linumusitatissimum). J. Foodsci 2005;70: 504-507.
citation: Ranilla LG, Apostolidis E, Genovese MI, Lajolo FM, Shetty K. Evaluation of indigenous grains from the Peruvian Andean region for antidiabetes and antihypertension potential using in vitro methods. J Med Food. 2009 Aug;12(4):704-13. doi: 10.1089/jmf.2008.0122.
citation: Repo-Carrasco-Valencia R, Hellströmb JK, Juha-Matti P, Mattila PH. Flavonoids and other phenolic compounds in andean indigenous grains: quinoa (chenopodium quinoa), kañiwa (chenopodium pallidicaule) and kiwicha (amaranthus caudatus). Food chemistry. 2010; 120(1):128-133.
citation: Shahidi F, Kim SK. Quality management of marine nutraceuticals. In: ho c-t, zheng qy, editors. Quality management of nutraceuticals. Acs symposium series 803. Washington, d.c.: american chemical society. 2002.p. 76-87.
citation: Spedding G, Ratty A, Middleton E Jr. Inhibition of reverse transcriptases by flavonoids. Antiviral Res. 1989 Sep;12(2):99-110. doi: 10.1016/0166-3542(89)90073-9.
citation: Stewart LK, Soileau JL, Ribnicky D, Wang ZQ, Raskin I, Poulev A, Majewski M, Cefalu WT, Gettys TW. Quercetin transiently increases energy expenditure but persistently decreases circulating markers of inflammation in C57BL/6J mice fed a high-fat diet. Metabolism. 2008 Jul;57(7 Suppl 1):S39-46. doi: 10.1016/j.metabol.2008.03.003.
citation: Torres-Bugarín O, Ramos-Ibarra ML. Utilidad de la prueba de micronúcleos y anormalidades nucleares en células exfoliadas de mucosa oral en la evaluación de daño genotóxico y citotóxico. Int. J. Morphol. 2013. 31(2):650-657.
citation: Torres-Bugarín O, Zavala-cerna MG, Macriz-Romero N, Flores-García A, Ramos-Ibarra ML. Procedimientos básicos de la prueba de micronúcleos y anormalidades nucleares en células exfoliadas de mucosa oral. El residente. 2013; (8):4-11.
citation: Voss S, Hesse A, Zimmermann DJ, Sauerbruch T, von Unruh GE. Intestinal oxalate absorption is higher in idiopathic calcium oxalate stone formers than in healthy controls: measurements with the [(13)C2]oxalate absorption test. J Urol. 2006 May;175(5):1711-5. doi: 10.1016/S0022-5347(05)01001-3.
citation: Hou Y, Aboukhatwa MA, Lei DL, Manaye K, Khan I, Luo Y. Anti-depressant natural flavonols modulate BDNF and beta amyloid in neurons and hippocampus of double TgAD mice. Neuropharmacology. 2010 May;58(6):911-20. doi: 10.1016/j.neuropharm.2009.11.002. Epub 2009 Nov 14.
citation: Zimmet P, M M Alberti KG, Serrano Rios M. [A new international diabetes federation worldwide definition of the metabolic syndrome: the rationale and the results]. Rev Esp Cardiol. 2005 Dec;58(12):1371-6. No abstract available. Spanish.
citation: Zong G, Demark-Wahnefried W, Wu H, Lin X. Effects of flaxseed supplementation on erythrocyte fatty acids and multiple cardiometabolic biomarkers among Chinese with risk factors of metabolic syndrome. Eur J Nutr. 2013 Aug;52(5):1547-51. doi: 10.1007/s00394-012-0461-y. Epub 2012 Nov 23.