Effect of Phytoecdysterone Administration in Subjects With Prediabetes

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03906201
• Other study ID #: 125/18
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: October 2019
• Source: University of Guadalajara
• Contact: ANA FLETES
• Phone: 011521-3310585200
• Email: anna.fletes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Ecdysterone
Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic

Other:
• Placebo
no pharmacologic effect

Locations

Country	Name	City	State
Mexico	Ana Fletes	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Waist Circumference	Waist circumference will be evaluated at baseline and at day 90 with a flexible tape	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Creatinine levels	Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques	90 days
Secondary	Alanine aminotransferase (ALT) levels	ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques	90 days
Secondary	Aspartate aminotransferase (AST) levels	AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques	90 days
Secondary	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

External Links

•   The journal of clinical and applied research and education. Diabetes Care. American Diabetes Association. Standards of Medical Care in Diabetes-2019.