CompletedPhase 4

Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.

Poland47 participantsStarted 2017-10-20

Plain-language summary

This study evaluates the effect of different doses of metformin on the function of endothelium in people with pre-diabetes. One group of the patients will receive metformin in dose: 1500 mg, the second one will receive 3000 mg/day. The parameters from healthy volunteers will be taken only at the study beginning to compare the test results with the parameters from patients with pre-diabetes. This group will be not treated with metformin (no intervention)

Who can participate

Age range

40 Years – 65 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 for treated groups ( A or B): * age: 40-65 years; * pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT; * without metformin before; * without ischemic heart disease in history; * without a stroke in a history; * without PAOD (peripheral arterial occlusive disease) in a history; * without active cancer in a history Exclusion Criteria for treated groups (A or B): * age \<40 or \>65; * diabetes; * taking metformin before study; * active cancer; * history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD); * serious gastrointestinal disease that may affect metformin tolerance; * renal failure with GFR\<45 ml/min/1.73m2; * alanin transaminase \> 3 x ULN Inclusion criteria for healthy volunteers: * age: 40-65 years; * no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT); * without metformin before; * without ischemic heart disease in history; * without a stroke in a history; * without PAOD (peripheral arterial occlusive disease) in a history; * without active cancer in a history

Questions worth asking your doctor

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

Serum Levels of Metformin at Different Time Points

Timeframe: 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of Arginine at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of ADMA at Different Time Points

Timeframe: before study start; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of SDMA at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of Citrulline at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of DMA at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Trial details

NCT IDNCT03398356

SponsorWroclaw Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-30

Results submitted2020-06-19

View on ClinicalTrials.gov More PreDiabetes trials

Plain-language summary

Who can participate

Age range

40 Years – 65 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.

What they're measuring

Serum Levels of Metformin at Different Time Points

Timeframe: 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of Arginine at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of ADMA at Different Time Points

Timeframe: before study start; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of SDMA at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of Citrulline at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start

Serum Levels of DMA at Different Time Points

Timeframe: Baseline; 6 weeks from treatment start; 12 weeks from treatment start; 15 weeks from treatment start