Effect of Phytoecdysterone Administration in Subjects With Prediabetes

Study Overview
=================
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).

Official Title
-----------------
Effect of Phytoecdysterone Administration on Cytotoxicity, Genotoxicity and Metabolic Control in Subjects With Prediabetes

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Ecdysterone
* Other: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment | Other: Placebo<br>* no pharmacologic effect<br>* Other names: magnesia stearate;|
| Experimental: Ecdysterone Group<br>Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment | Dietary Supplement: Ecdysterone<br>* Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PreDiabetes, Ecdysterone, Genotoxicity, Citotoxicity, Micronuclei, Glycemic Control