Phase 4
Completed N=47
Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.
Prediabetes · Impaired Fasting Glucose (IFG) · Impaired Glucose Tolerance (IGT)
Source: ClinicalTrials.gov NCT03398356 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Serum Levels of Metformin at Different Time Points — 4.36; 4.25; 5.09; 7.42 µM
◆ Published Evidence
Emerging
16citations · ~3 / year
Low metformin dose and its therapeutic serum concentration in prediabetes.
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)
Linked Publications (3)
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Low metformin dose and its therapeutic serum concentration in prediabetes.
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Metformin has no impact on nitric oxide production in patients with pre-diabetes.
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The impact of Sample Handling Time on metformin serum concentration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Levels of Metformin at Different Time Points |
4.36; 4.25; 5.09; 7.42; 4.66; 4.01 | — |
| PRIMARY Serum Levels of Arginine at Different Time Points |
112.18; 111.72; 107.72; 97.69; 104.72; 103.76 | — |
| PRIMARY Serum Levels of ADMA at Different Time Points |
0.51; 0.57; 0.52; 0.55; 0.50; 0.52 | — |
| PRIMARY Serum Levels of SDMA at Different Time Points |
0.40; 0.45; 0.41; 0.42; 0.39; 0.39 | — |
| PRIMARY Serum Levels of Citrulline at Different Time Points |
21.73; 28.08; 25.95; 27.01; 26.93; 29.77 | — |
| PRIMARY Serum Levels of DMA at Different Time Points |
1.71; 2.07; 1.63; 1.89; 1.62; 1.84 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT03398356) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.