Effect of Phytoecdysterone Administration in Subjects With Prediabetes (NCT03906201) | Clinical Trial Compass
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 range
30 Years – 60 Years
Sex
ALL
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
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the number of micronuclei after 90 days
Timeframe: 90 days
2
Changes in fasting glucose levels after 90 days of intervention with betaecdysterone and placebo
Timeframe: 90 days
3
Changes in glycosylated hemoglobin (A1C) after 90 days of intervention with betaecdysterone and placebo