Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.

Summary

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Description

A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accordance with the American Diabetes Association without treatment. Patients with one or more of the foll...

A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accordance with the American Diabetes Association without treatment. Patients with one or more of the following criteria will be excluded: History of liver, kidney or heart disease; systolic blood pressure ? 140 mmHg, diastolic blood pressure ? 90 mmHg, HbA1c ?6.5%, triglycerides ? 400 mg/dL, total cholesterol ?240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on glucose levels. They will be assigned randomly two groups of 15 patients; one of the groups will receive 750 mg of metformin twice at day (before breakfast and dinner) for 13 weeks. The other group will receive 400 mg of probiotics 1 time at day (before breakfast) and placebo pill (before dinner) for 13 weeks. They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated area under curve of glucose an insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index). This protocol It´s already approved by the local ethics committee and written informed consent it´s going to be obtained from all volunteers. Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. Will be used Wilcoxon range test for identification of differences between baseline and final evaluation of each intervention group, Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered satitistical significance p >0.05.

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