PreDiabetes
Conditions
Keywords
PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control
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).
Interventions
DIETARY_SUPPLEMENTEcdysterone
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
OTHERPlacebo
no pharmacologic effect
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Randomized double-blind clinical trial plus control group
Intervention model description
cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the number of micronuclei after 90 days | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 90 days | Waist circumference will be evaluated at baseline and at day 90 with a flexible tape |
| Total Cholesterol | 90 days | 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 |
| High Density Lipoprotein (c-HDL) levels | 90 days | 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 | 90 days | 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 |
| Triglycerides levels | 90 days | 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 |
| Alanine aminotransferase (ALT) levels | 90 days | ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques |
| Aspartate aminotransferase (AST) levels | 90 days | AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques |
| Blood pressure | 90 days | 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 |
| Creatinine levels | 90 days | Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques |
| Body Weight | 90 days | 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 | 90 days | 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 |
Countries
Mexico
Contacts
Primary ContactANA FLETES
Outcome results
None listed