Effect of Phytoecdysterone Administration in Subjects With Prediabetes

Not Applicable

• Conditions: PreDiabetes
• Interventions: Dietary Supplement: Ecdysterone; Other: Placebo

• Registration Number: NCT03906201
• Lead Sponsor: University of Guadalajara

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).

Study Timeline

• Study First Submitted: 2018-09-11
• Study Start: 2019-02-06
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ecdysterone Group	Ecdysterone	Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment
Control Group	Placebo	Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
Waist Circumference	90 days	Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
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
Creatinine levels	90 days	Creatinine levels will be evaluated at baseline and day 90 with 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
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

Trial Locations

Locations (1)

Ana Fletes; 🇲🇽 Guadalajara, Jalisco, Mexico