Back to resultsEffect of Phytoecdysterone Administration in Subjects With Prediabetes
Primary Purpose
PreDiabetes
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Ecdysterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control
Eligibility Criteria
Inclusion Criteria:
- - Fasting Plasma Glucose between 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L)
- - Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
- - A1C 5.7-6.4% (39-47 mmol/mol).
- - Body Mass Index >25 kg/m2 or >23 kg/m2
- Adults who have one or more of the following risk factors:
- First-degree relative with diabetes
- High-risk race/ethnicity
- History of CVD
- - Blood Pressure <140/90 mmHg without therapy for hypertension
- - 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.
Sites / Locations
- Ana FletesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control Group
Ecdysterone Group
Arm Description
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment
Outcomes
Primary Outcome Measures
Changes in the number of micronuclei after 90 days
The number of micronuclei will be evaluated at baseline and day 90 with Schmidt technique by giemsa/wright and the entered values reflect the number of micronuceli at day 90
Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo
The fasting glucose levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at day 90
Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
Glycosylated hemoglobin will be evaluated at baseline and day 90 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at day 90
Secondary Outcome Measures
Body Weight
The body weight will be measured at baseline, day 30, day 60 and day 90 with a bioimpedance balance and the entered values reflect the body weight at 90 days
Body Mass Index
Body Mass Index will be calculated at baseline, day 30, day 60 and day 90 with the Quetelet index formula and the entered values reflect the body mass index at day 90
Waist Circumference
Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
Total Cholesterol
Total cholesterol levels will be evaluated at baseline and day 90 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at day 90
Triglycerides levels
Triglycerides levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at day 90
High Density Lipoprotein (c-HDL) levels
c-HDL levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at day 90
Low Density Lipoproteins (c-LDL) levels
c-LDL levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at day 90
Creatinine levels
Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques
Blood pressure
Blood pressure will be measured at baseline and day 90 with a digital sphygmomanometer and the entered values reflect the blood pressure at day 90
Full Information
NCT ID
NCT03906201
First Posted
September 11, 2018
Last Updated
October 29, 2019
Sponsor
University of Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT03906201
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
Masking
Care ProviderOutcomes Assessor
Masking Description
Randomized double-blind clinical trial plus control group
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment
Arm Title
Ecdysterone Group
Arm Type
Experimental
Arm Description
Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Ecdysterone
Intervention Description
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
magnesia stearate
Intervention Description
no pharmacologic effect
Primary Outcome Measure Information:
Title
Changes in the number of micronuclei after 90 days
Description
The number of micronuclei will be evaluated at baseline and day 90 with Schmidt technique by giemsa/wright and the entered values reflect the number of micronuceli at day 90
Time Frame
90 days
Title
Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo
Description
The fasting glucose levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at day 90
Time Frame
90 days
Title
Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
Description
Glycosylated hemoglobin will be evaluated at baseline and day 90 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at day 90
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Body Weight
Description
The body weight will be measured at baseline, day 30, day 60 and day 90 with a bioimpedance balance and the entered values reflect the body weight at 90 days
Time Frame
90 days
Title
Body Mass Index
Description
Body Mass Index will be calculated at baseline, day 30, day 60 and day 90 with the Quetelet index formula and the entered values reflect the body mass index at day 90
Time Frame
90 days
Title
Waist Circumference
Description
Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
Time Frame
90 days
Title
Total Cholesterol
Description
Total cholesterol levels will be evaluated at baseline and day 90 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at day 90
Time Frame
90 days
Title
Triglycerides levels
Description
Triglycerides levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at day 90
Time Frame
90 days
Title
High Density Lipoprotein (c-HDL) levels
Description
c-HDL levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at day 90
Time Frame
90 days
Title
Low Density Lipoproteins (c-LDL) levels
Description
c-LDL levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at day 90
Time Frame
90 days
Title
Creatinine levels
Description
Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Time Frame
90 days
Title
Alanine aminotransferase (ALT) levels
Description
ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Time Frame
90 days
Title
Aspartate aminotransferase (AST) levels
Description
AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques
Time Frame
90 days
Title
Blood pressure
Description
Blood pressure will be measured at baseline and day 90 with a digital sphygmomanometer and the entered values reflect the blood pressure at day 90
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Fasting Plasma Glucose between 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L)
- Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
- A1C 5.7-6.4% (39-47 mmol/mol).
- Body Mass Index >25 kg/m2 or >23 kg/m2
- Adults who have one or more of the following risk factors:
First-degree relative with diabetes
High-risk race/ethnicity
History of CVD
- Blood Pressure <140/90 mmHg without therapy for hypertension
- 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANA FLETES
Phone
011521-3310585200
Email
anna.fletes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANA FLETES
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ana Fletes
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANA FLETES
Phone
3310585200
Ext
34097/34098
Email
anna.fletes@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
THE RESULTS GENERATED AND THE PERSONAL DATA OF THE PARTICIPANTS ARE ON THE CONSENT OF THE SUBJECT OF STUDY AND OF THE PRINCIPAL INVESTIGATOR. THEY ARE EXTRICTLY CONFIDENTIAL AND WILL ONLY BE USED BY HOSPITAL DOCTORS
Citations:
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
Results Reference
background
PubMed Identifier
21164186
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
15309439
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.
Results Reference
background
PubMed Identifier
24912714
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.
Results Reference
background
Citation
FAO, 2013. Food and agriculture organization of the united nations rome. Http://www.fao.org/docrep/018/i3300e/i3300e00.pdf
Results Reference
background
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
Results Reference
background
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
Results Reference
background
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
Results Reference
background
PubMed Identifier
26115598
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.
Results Reference
background
PubMed Identifier
25868129
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.
Results Reference
background
PubMed Identifier
16129722
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.
Results Reference
background
Citation
Lizarzaburu-Robles JC. Síndrome metabólico: metabolicsyndrome: concept and practical application. An facmed. 2013;74(4):315-320.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
18467024
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.
Results Reference
background
Citation
Ojeda-Lavin A. Proyecciones de la población 2010-2050. Consejo nacional de población méxico. 2014.http://www.conapo.gob.mx/es/conapo/proyecciones.
Results Reference
background
Citation
Omsa. Datos y cifras. 10 datos sobre la obesidad. 2015. Disponible en: http://www.who.int/features/factfiles/obesity/facts/es/index1.html
Results Reference
background
PubMed Identifier
23610908
Citation
Cuevas ZO, Sangronis E. [Characterization of flaxseed (Linum usitatissimum L.) grown in Venezuela]. Arch Latinoam Nutr. 2012 Jun;62(2):192-200. Spanish.
Results Reference
background
PubMed Identifier
18537130
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.
Results Reference
background
PubMed Identifier
16719498
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.
Results Reference
background
Citation
Ramcharitar A, Badrie N, Mattfeldtbeman M, Matsuo H, Ridley C. Consumeracceptability of muffinswithflaxseed (linumusitatissimum). J. Foodsci 2005;70: 504-507.
Results Reference
background
PubMed Identifier
19735168
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
2480745
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.
Results Reference
background
PubMed Identifier
18555853
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
16600737
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.
Results Reference
background
PubMed Identifier
19917299
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.
Results Reference
background
PubMed Identifier
16371194
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. Erratum In: Rev Esp Cardiol. 2006 Feb;59(2):185. Spanish.
Results Reference
background
PubMed Identifier
23179200
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.
Results Reference
background
Links:
URL
http://fmdiabetes.org/wp-content/uploads/2019/01/ada-2019.pdf
Description
The journal of clinical and applied research and education. Diabetes Care. American Diabetes Association. Standards of Medical Care in Diabetes-2019.
Learn more about this trial
Effect of Phytoecdysterone Administration in Subjects With Prediabetes
We'll reach out to this number within 24 hrs