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

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.

Inclusion criteria

• Patients both sexes
• Age between 31 and 60 years
• Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %)
• Body Mass Index from 25 to 34.9 kg/m2
• Stable weight at least the previous last 3 months (weight variation less than 10%)
• Acceptance and signing of informed consent

Exclusion criteria

• History of kidney, liver or heart disease
• Women with confirmed or suspected pregnancy
• Women under lactation and/or puerperium
• Physical impossibility for taking pills
• Hypersensibility to ingredients of intervention
• Consumption of medications or supplements with effects on glucose levels
• Systolic blood pressure ≥ 140 mmHg
• Diastolic blood pressure ≥ 90 mmHg
• HbA1c ≥6.5%
• Triglycerides ≥ 400 mg/dL
• Total cholesterol ≥ 240 mg/dL