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

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wroclaw Medical University
• Treatments: Metformin; Nitric Oxide

Criteria

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