PreDiabetesNCT03906201
Effect of Phytoecdysterone Administration in Subjects With Prediabetes
A study testing Ecdysterone in people with PreDiabetes, run by University of Guadalajara at 1 site in Mexico.
Trial 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%. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Ecdysterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 6 Feb 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Show all 10Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Ana Fletes
Guadalajara, Jalisco, 44340
ANA FLETES, 3310585200 ext. 34097/34098, anna.fletes@gmail.com
About this study
Official title: Effect of Phytoecdysterone Administration on Cytotoxicity, Genotoxicity and Metabolic Control in Subjects With Prediabetes
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.
Read the 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).
- Conditions
- PreDiabetes
- Being tested
- Ecdysterone, Placebo
- Keywords
- PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcdysteroneDietary supplement
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
PlaceboOther
Also called magnesia stearate
no pharmacologic effect
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment Receives: Other: Placebo |
| Ecdysterone Group | Experimental | Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment Receives: Dietary Supplement: Ecdysterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
Secondary outcomes (11)
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
Measured: 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
Measured: 90 days
Waist Circumference
Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
Creatinine levels
Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Measured: 90 days
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Measured: 90 days
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques
Measured: 90 days
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start6 Feb 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Lilia Fletes Rayas, University of Guadalajara
- Investigators
- ANA FLETES, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906201
- Sponsor's protocol ID
- 125/18
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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
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.
PubMed 21164186•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
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.
PubMed 15309439Graf 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.
PubMed 24912714FAO, 2013. Food and agriculture organization of the united nations rome. Http://www.fao.org/docrep/018/i3300e/i3300e00.pdf
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
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
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
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.
PubMed 26115598Karaman 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.
PubMed 25868129Leon-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.
PubMed 16129722Lizarzaburu-Robles JC. Síndrome metabólico: metabolicsyndrome: concept and practical application. An facmed. 2013;74(4):315-320.
Kaufer-Horwitz M, Toussaint G. Indicadores antropométricos para evaluar sobrepeso y obesidad en pediatría. Bol. Med. Hosp. Infant. Mex; 2008;65(6): 502-518.
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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phytoecdysterone Administration on Cytotoxicity, Genotoxicity and Metabolic Control in Subjects With Prediabetes
- ClinicalTrials.gov ID
- NCT03906201
- Acronym / sponsor ID
- 125/18
- Conditions
- PreDiabetes
- Keywords
- PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: PlaceboSubjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment |
| Ecdysterone Group | Experimental | Dietary Supplement: EcdysteroneSubjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- - 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EcdysteroneFood supplement of plant origin with pronounced biological activity and potentially hypoglycaemic | Dietary supplement | Ecdysterone Group |
| PlaceboAlso: magnesia stearateno pharmacologic effect | Other | Control Group |
Primary outcome
Changes in the number of micronuclei after 90 days
Time frame: 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
Time frame: 90 days
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
Time frame: 90 days
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
11 secondary outcomes
Body Weight
Time frame: 90 days
Body Mass Index
Time frame: 90 days
Waist Circumference
Time frame: 90 days
Total Cholesterol
Time frame: 90 days
Triglycerides levels
Time frame: 90 days
High Density Lipoprotein (c-HDL) levels
Time frame: 90 days
Low Density Lipoproteins (c-LDL) levels
Time frame: 90 days
Creatinine levels
Time frame: 90 days
Alanine aminotransferase (ALT) levels
Time frame: 90 days
Aspartate aminotransferase (AST) levels
Time frame: 90 days
Blood pressure
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- BackgroundÁlvarez-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
- Background: PubMed 21164186Andreassi 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.
- Background•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
- Background: PubMed 15309439Berti 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.
- Background: PubMed 24912714Graf 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.
- BackgroundFAO, 2013. Food and agriculture organization of the united nations rome. Http://www.fao.org/docrep/018/i3300e/i3300e00.pdf
- BackgroundFAO. 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
- BackgroundFiguerola 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
- BackgroundGutiérrez 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
- Background: PubMed 26115598Harishankar 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.
- Background: PubMed 25868129Karaman 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.
- Background: PubMed 16129722Leon-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.
- The journal of clinical and applied research and education. Diabetes Care. American Diabetes Association. Standards of Medical Care in Diabetes-2019.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANA FLETES principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecdysterone in people with PreDiabetes, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANA FLETES (011521-3310585200, anna.fletes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of micronuclei after 90 days (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906201, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.