UnknownNot Applicable

Effect of Phytoecdysterone Administration in Subjects With Prediabetes

Mexico34 participantsStarted 2019-02-06

Plain-language 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.

Who can participate

Age range30 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. \- 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)

Exclusion criteria

✕.- 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.

What they're measuring

Changes in the number of micronuclei after 90 days

Timeframe: 90 days

Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo

Timeframe: 90 days

Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo

Timeframe: 90 days

Trial details

NCT IDNCT03906201

SponsorUniversity of Guadalajara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-31

Contact for this trial

ANA FLETES

011521-3310585200 anna.fletes@gmail.com

View on ClinicalTrials.gov More PreDiabetes trials

Plain-language summary

Who can participate

Age range30 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. \- 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)

Exclusion criteria

✕.- 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.

What they're measuring

Changes in the number of micronuclei after 90 days

Timeframe: 90 days

Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo

Timeframe: 90 days

Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo

Timeframe: 90 days