Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 12 Week, Randomized, Double-blind, Placebo-controlled, Phase II Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus With Different Course of Disease and Treatment
Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by
hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and
macrovascular complications associated with the increased prevalence of cardiovascular
disease (CVD) in diabetics.
Although genetic predisposition determines individual susceptibility to T2DM, external
factors such as an unhealthy diet and a sedentary lifestyle condition the onset of the
disease.
Since T2DM is a multifactorial disease, many authors have studied the possible role of the
microbiota and its alterations in the pathophysiology of the disease. There is evidence that
in T2DM there are alterations in the proportion of Firmicutes, Bacteroidetes and
Proteobacteria, and a smaller amount of bifidobacteria with anti-inflammatory properties.
Probiotics are living microorganisms present in food that, if consumed in sufficient
quantities, can improve health. In general, probiotics protect the patient through
immunomodulation, protecting him from infections, increasing the activation of mononuclear
cells and lymphocytes.
The investigational product is a supplement to the probiotic Bifidobacterium animalis subsp.
lactis (BPL-1) CECT 8145. There are numerous studies carried out on different strains of
GLP-1 that demonstrate its safety. Many of them are commonly used in the food industry, not
only because of their proven safety, but also because of their viability until consumption.
This clinical trial is proposed as an interdisciplinary study that can contribute to the
characterization of the efficacy of treatment with probiotics in patients with T2DM of
different stages of evolution, without and with hepatic involvement.
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