Effect of Phytoecdysterone Administration in Subjects With Prediabetes

October 29, 2019 updated by: Ana Lilia Fletes Rayas, University of Guadalajara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Recruiting
        • Ana Fletes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the number of micronuclei after 90 days
Time Frame: 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
Time Frame: 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
90 days
Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo
Time Frame: 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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 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
90 days
Body Mass Index
Time Frame: 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
90 days
Waist Circumference
Time Frame: 90 days
Waist circumference will be evaluated at baseline and at day 90 with a flexible tape
90 days
Total Cholesterol
Time Frame: 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
90 days
Triglycerides levels
Time Frame: 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
90 days
High Density Lipoprotein (c-HDL) levels
Time Frame: 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
90 days
Low Density Lipoproteins (c-LDL) levels
Time Frame: 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
90 days
Creatinine levels
Time Frame: 90 days
Creatinine levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
90 days
Alanine aminotransferase (ALT) levels
Time Frame: 90 days
ALT levels will be evaluated at baseline and day 90 with enzymatic/colorimetric techniques
90 days
Aspartate aminotransferase (AST) levels
Time Frame: 90 days
AST levels will be evaluated at baseline and day 90 enzymatic/colorimetric techniques
90 days
Blood pressure
Time Frame: 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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: ANA FLETES, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

THE RESULTS GENERATED AND THE PERSONAL DATA OF THE PARTICIPANTS ARE ON THE CONSENT OF THE SUBJECT OF STUDY AND OF THE PRINCIPAL INVESTIGATOR. THEY ARE EXTRICTLY CONFIDENTIAL AND WILL ONLY BE USED BY HOSPITAL DOCTORS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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