Metabolic Effects of Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut
      microbiota) can function as an environmental factor that modulates the amount of body fat.
      Obese individuals have an altered gut microbiota and germ-free mice are resistant to
      developing diet-induced obesity and have lower fasting insulin and glucose concentrations and
      shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus
      Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body weight in obese
      adults possibly by reducing lipid absorption and inflammatory status. However, there are no
      controlled studies to the investigators knowledge that address whether probiotic
      supplementation affects glucose metabolism. The investigators hypothesis is that
      supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2
      diabetes patients. In addition, the investigators will explore possible mechanisms behind the
      antihyperglycemic action of Lactobacillus Reuteri.
    

Detailed description: 
      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.
    

Intervention name(s): Lactobacillus Reuteri; Lactobacillus Reuteri DSM17938
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.; Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment