| Outcome Measures: |
Primary: change from baseline in the fecal microbiota composition by detecting bacteria families with help of relative abundance (%) and diversity metrics, Faeces samples will be collected at baseline, after 2 months and after 4 months of Metformin treatment and analysed using 16S rRNA sequencing, whole genome shotgun sequencing and metagenomic analyses, 4 months | Secondary: genetic correlation between Microbiota and gastrointestinal side effects, The microbiota genome and the relation to the appearance of gastrointestinal side effects will be analysed., 4 months|number of patients with gastrointestinal side effects, A questionnaire will be answered at baseline, after 2 and 4 months and refers to a period of 2 weeks before study visit. Six different side effects will be monitored: loss of appetite, nausea, vomiting, diarrhea, meteorism, stomach ache., 4 months|rate of gastrointestinal side effects, Changes in the rate of side effects using questionnaire at baseline, after 2 and 4 months.The answer possibilities are: never, one or a few times, daily, multiple times a day., 4 months|time to first appearance of gastrointestinal side effects, How many months till the onset of side effects during metformin treatment: depending on the time of assessment, 2 or 4 months, 4 months|time to first appearance of side effects which requires dose changes in the Metformin treatment, Analysing changes in metformin treatment and relation to appearance of side effects, 4 months|time to first appearance of side effects which requires termination of the Metformin treatment, Analysing length of metformin treatment and relation to appearance of side effects, 4 months|correlation between microbiota and beneficial glucose lowering response, Plasma glucose will be analysed at baseline, after 2 and 4 months of Metformin treatment and correlated to the changes in the composition of microbiota., 4 months
|
