Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.
Condition: PreDiabetes; Impaired Fasting Glucose (IFG); Impaired Glucose Tolerance (IGT)
MeSH terms: Prediabetic State; Glucose Intolerance
Intervention: Metformin
Intervention description: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg
for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The group of patients taking the drug at the target dose of 3 x 1000 after 4 weeks returned to the dose of 3 x 500 mg. The group of patients taking the drug at the target dose 3 x 500 mg consequently had this dose during the whole study period.
The basic parameters and biochemical parameters from healthy individuals at the beginning of the study were assessed to compare with patients with pre-diabetes. This group did not take the metformin and thus did not have further examination and lab-tests during the study.
Masking: Single (Investigator)
Masking description: At the beginning of the study, patients are assigned a number by a nurse and are assigned to group A or B according to ID. When analyzing the results, the researchers only knows the numbers of blood samples.
Enrollment: 47.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prediabetes; impaired fasting glucose; impaired glucose tolerance; metformin; nitric oxide

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)
    

Eligibility 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