Effect of Phytoecdysterone Administration in Subjects With Prediabetes

University of Guadalajara

Status: Unknown

Conditions: PreDiabetes

Treatments: Dietary Supplement: Ecdysterone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03906201

125/18

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Control Group

Experimental group

Description:

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

Treatment:

Other: Placebo

Ecdysterone Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ecdysterone