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 range40 Years – 65 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 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

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 range40 Years – 65 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.

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