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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment |
|
| Ecdysterone Group | Experimental | Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecdysterone | Dietary Supplement | Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| Body Mass Index |
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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:
- 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANA FLETES | Contact | 011521-3310585200 | anna.fletes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ANA FLETES | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Fletes | Recruiting | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 21164186 | Background | 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. | |
| 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 | ||
| 15309439 |
| Label | URL |
|---|---|
| The journal of clinical and applied research and education. Diabetes Care. American Diabetes Association. Standards of Medical Care in Diabetes-2019. | View source |
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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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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004441 | Ecdysterone |
| ID | Term |
|---|---|
| D026461 | Ecdysteroids |
| D002783 | Cholestenones |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
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Randomized double-blind clinical trial plus control group
| Placebo | Other | no pharmacologic effect |
|
|
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
| 90 days |
| Waist Circumference | Waist circumference will be evaluated at baseline and at day 90 with a flexible tape | 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 | 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 | 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 | 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 | 90 days |
| Creatinine levels | Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques | 90 days |
| Alanine aminotransferase (ALT) levels | ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques | 90 days |
| Aspartate aminotransferase (AST) levels | AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques | 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 | 90 days |
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| D004700 | Endocrine System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007301 | Insect Hormones |
| D007447 | Invertebrate Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |