Impacto de Lactobacillus Reuteri DSM 17938 en pacientes con diabetes tipo 2

This is a double-blind, placebo controlled randomised study with three parallel groups of type 2 diabetes (T2D) patients receiving either placebo, Lactobacillus reuteri DSM 17938, 1 x 108 (colony-forming units) CFU or Lactobacillus reuteri DSM 17938 CFU 1 x 1010. The study will be performed at the Clinical Trial Centre (CTC) at the Sahlgrenska University Hospital in Gothenburg. The investigators will recruit forty-five T2D patients of both gender 50-75 yrs, with waist circumference > 80 cm and > 94 cm in women and men, respectively, HbA1c 50-90 mmol/mol and treatment to achieve normoglycemia with lifestyle, insulin with or without oral hypoglycemic agents. Patients who meet all inclusion criteria will be asked to join the study and will be given full written information on the study before being asked to sign a written consent form. Recruited patients will then undergo a baseline examination with collection of demographic data, fasting blood and urine samples and measurements of blood pressure. After less than three weeks, the patients return for 1.5 days of investigations. At baseline, urine, blood and faeces samples are taken but also body composition assessed with (Dual Energy X-ray Absorbtion) DEXA, proton magnetic resonance spectroscopy to quantify liver fat content, magnetic resonance imaging (MRI) for determination of visceral adipose tissue and subcutaneous adipose tissue area at the level of L4-L5, a euglycemic hyperinsulinemic clamp at 120 milliunits (mU)/m2/min and finally in conjunction with the glucose clamp, indirect calorimetry, pulse wave analysis and abdominal subcutaneous needle biopsy. At visit 3 the glucose clamp, day 0, patients will be randomized and given the study medication for the whole study period with instructions to take one dose per day (in the morning before breakfast). Patients then return at day 28 and day 56 for urine, faeces and blood sampling. After 12 weeks supplementation on day 84±7 days, blood, urine and faeces samples and all procedures performed at baseline in conjunction with day 0 are repeated. Moreover, patients return study medications not being used. Finally, patients who completed the study and will be asked to book a visit to their ordinary diabetes team.