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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
no pharmacologic effect
Ana Fletes
Guadalajara, Jalisco, Mexico
RECRUITINGChanges 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
Time frame: 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
Time frame: 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
Time frame: 90 days
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
Time frame: 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
Time frame: 90 days
Waist Circumference
Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
Time frame: 90 days
Total Cholesterol
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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
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
Time frame: 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
Time frame: 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
Time frame: 90 days
Creatinine levels
Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Time frame: 90 days
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
Time frame: 90 days
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques
Time frame: 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
Time frame: 90 days