Status:
COMPLETED
Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.
Lead Sponsor:
Wroclaw Medical University
Conditions:
PreDiabetes
Impaired Fasting Glucose (IFG)
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
Brief 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 secon...
Detailed Description
In addition to exercise and diet, metformin is a medicine used to treat diabetes mellitus (DM) and pre-diabetic (pre-DM) conditions. This drug improves insulin sensitivity in both groups of patients (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03398356
Start Date
October 20 2017
End Date
April 30 2019
Last Update
May 27 2022
Active Locations (1)
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1
NZOZ Nowy Dwór
Wroclaw, Lower Silesian Voivodeship, Poland, 54-438