Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

Launched by MEDICAL UNIVERSITY OF SILESIA · Sep 12, 2019

Keywords

ClinConnect Summary

The optimal daily dose of metformin is thought to be 2000 mg, however patients with metformin intolerance cannot reach this target dose. Participate in this study are metformin intolerant. Metformin intolerant patients have been defined as those not able to be treated with the metformin daily dose exceeding 1500 mg due to gastrointestinal upset. Patient's metformin intolerance assessment will be questionnaire based (questionnaire adapted from Laura J. Mc Creight et al.). Patients will fill out questionnaires regarding the gastrointestinal symptoms associated with metformin at a dose they di...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent for participation in the clinical trial
• • 2. Age 18-75 years
• • 3. Type 2 diabetes mellitus diagnosed at minimum 6 months prior to the study
• • 4. Metformin intolerance defined as gastrointestinal adverse effects occurrence at the daily metformin dose higher than 1500 mg assessed by the Questionnaire adapted from Laura J. McCreight et al., which disappeared or decreased to the accepted tolerable level after dose reduction to 1500 mg per day.
• • 5. Metformin treatment in the daily dose not higher than 1500 mg
• • 6. Stable metformin dose in the last 3 months before inclusion to the study
• Exclusion Criteria:
• • 1. Estimated Glomerular Filtration Rate (eGFR) \< 60 ml /min/ 1.73m2
• • 2. Elevation of ALT and aspartate aminotransferase (AST) activity in the blood serum, three times above the reference value
• • 3. Chronic bowel disease
• • 4. Any other acute or chronic disease that may cause gastrointestinal symptoms
• • 5. Acute or chronic pancreatitis
• • 6. Chronic alcohol consumption \>30 g/day for men and \> 20 g/day for women
• • 7. Antibiotic therapy in the last 6 months prior to the study
• • 8. Probiotics use in the last 3 months before the study
• • 9. Chronic use of steroid drugs or other immunomodulators
• • 10. Heart failure (New York Heart Association (NYHA) III and IV)
• • 11. Pregnancy or breast feeding