Effect of Phytoecdysterone Administration in Subjects With Prediabetes

Last updated: October 29, 2019
Sponsor: University of Guadalajara
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes (Pediatric)

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT03906201
125/18
  • Ages 30-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 >0.250mg/dL (2.82 mmol/L)

Exclusion

Exclusion Criteria:

1.- Pregnant women or lactic period 2- Patients with some other chronic degenerativedisease 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 Design

Total Participants: 34
Study Start date:
February 06, 2019
Estimated Completion Date:
July 31, 2020

Study 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).

Connect with a study center

  • Ana Fletes

    Guadalajara, Jalisco 44340
    Mexico

    Active - Recruiting

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