Probiotics in Diabesity: A Pilot Study
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality.
      Probiotic modulation of gut flora is a possible therapeutic mechanism.

      The aim of this study is to investigate and compare thoroughly the effect of a multispecies
      probiotic on glycaemic control, gut microbiota and gut permeability in patients with
      metabolic syndrome and diabetes.
    

Detailed description: 
      Obesity and diabetes probably represent the most challenging threat to public health in the
      21st century. The World Health Organization (WHO) predicts that by 2015 approximately 2.3
      billion adults will be overweight (BMI 25-29.9 kg/m²), and more than 700 million will be
      obese (BMI 30 kg/m² or more). In addition, currently 285 million people worldwide suffer from
      type 2 diabetes (T2DM), and this number is predicted to increase to 439 million by 2030. T2DM
      raises the risk for cardiovascular morbidity and mortality, as well as eye problems, nerve
      damage and kidney diseases. Previous studies demonstrated that the impact of diabetes on
      everyday life and the likelihood of costly and disabling complications can be reduced by more
      intensive management of glucose, blood pressure and cholesterol. Weight reduction is the most
      desired but also most difficult to achieve treatment option in obesity, that is able to
      prevent secondary complications of obesity and T2DM.

      Since weight reduction by diet and increased physical activity alone is difficult to achieve
      in morbidly obese subjects, other, more aggressive approaches, such as bariatric surgery have
      been invented.

      Recent preclinical and clinical studies have indicated an important influence of the
      intestinal microbiome (gut metagenome) on obesity and associated metabolic disorders
      (metabolic syndrome, type 2 diabetes, metabolic liver diseases, cardiovascular diseases). For
      instance, the cecum microbiota of rodents was found to be significantly different in obese
      than in lean mice. This finding of altered gut microbiota was then confirmed and extended to
      humans. Additionally, these investigations in humans demonstrated that as obese people lose
      weight, the composition of microflora shifted, and more closely resembled that of the lean
      individuals. This suggests that the microflora might be involved in the pathogenesis of
      obesity, insulin resistance and T2DM by having an impact on gut permeability and chronic
      inflammation. Probiotic, prebiotic or synbiotic interventions have been shown to be effective
      in modulating gut permeability and gut microbiota in animals and thereby modulating chronic
      inflammation and metabolic disorders in animal models. In humans this has not been shown
      unequivocally so far.

      However, it is yet unknown, who will benefit from which intervention and why individuals
      respond differently to these interventions.

      The aim of this study is to investigate and compare thoroughly the effect of a multispecies
      probiotic on glycaemic control, gut microbiota and gut permeability in patients with
      metabolic syndrome and diabetes. The investigators aim to access changes in insulin
      sensitivity, islet function and the secretion of gut hormones. In addition, the investigators
      will investigate changes in gut microbiota and gut permeability to understand the underlying
      mechanism. After investigating the mechanism the overarching aim is to identify biomarkers,
      which would allow better prediction of treatment success. In future this would allow
      tailoring obesity and diabetes treatment in order to give every patient the optimal treatment
      at lowest costs.
    

Intervention name(s): Winclove 851 and 110; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): prebiotic and probiotic mixture; white powder without pro/probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention