Effect of Phytoecdysterone Administration in Subjects With Prediabetes

NCT03906201 | Unknown DMC

• 1 other identifier: 125/18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

PreDiabetes; Ecdysterone; Genotoxicity; Citotoxicity; Micronuclei; Glycemic Control

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Body Weight

  90 days

• Body Mass Index

  90 days

• Waist Circumference

  90 days

• Total Cholesterol

  90 days

• Triglycerides levels

  90 days

Study Arms (2)

Control Group

EXPERIMENTAL

Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 with placebo treatment

Other: Placebo

Ecdysterone Group

EXPERIMENTAL

Subjects diagnosed with prediabetes according to the criteria of the American Diabetes Association, version 2019 whit ecdysterone treatment

Dietary Supplement: Ecdysterone

Interventions

Ecdysterone DIETARY_SUPPLEMENT

Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic

Ecdysterone Group

Placebo OTHER

no pharmacologic effect

Also known as: magnesia stearate

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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)

You may not qualify if:

• Pregnant women or lactic period 2- Patients with some other chronic degenerative disease like diabetes mellitus 2 with pharmacologic treatment.
• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Ana Fletes

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

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Related Links

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

MeSH Terms

Conditions

Prediabetic State

Interventions

Ecdysterone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ecdysteroids; Cholestenones; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Insect Hormones; Invertebrate Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• ANA FLETES

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANA FLETES

CONTACT

011521-3310585200; anna.fletes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomized double-blind clinical trial plus control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseach Professor Associated

Model Details: cohort populations with diagnostic metabolic syndrome treatment base with ecdysterone for 90 days

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: April 8, 2019
• Study Start: February 6, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)