Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: BPL-1 Probiotic capsules
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients between the ages of 18-75 (inclusive) BMI ≥ 27 Glycated hemoglobin > 5,6 and/or fasting glucose > 100 mg/dl and/or being on active treatment with at least one antidiabetic medication Subjects must be able to provide written informed consent Females of childbearing potential must have a previous negative pregnancy test and must agree to use adequate contraception during their participation in the study Exclusion Criteria: Crohn's disease, liver cirrhosis, human immunodeficiency virus (HIV) or any other active systemic bacterial, viral or fungal infections BMI > 42 Severe hypoglycemias within 3 months prior to the start date of the study Abnormal glycated hemoglobin measurements (over 8%) prior to the start date of the study Prescription of a new antidiabetic medication in the last 6 months Celiac disease or any other food intolerances Use of antibiotics, probiotics and/or prebiotics within 2 weeks prior to the start date of the study Chronic liver disease with a C Child-Plug score, chronic kidney disease with creatinine clearance < 50 ml/min as well as any other clinically significant conditions including pulmonary, neurological and cardiovascular diseases according to the investigators medical opinion Patients with history or presence of malignancy who have been treated with systemic antineoplastic therapy within 6 months prior to the start date of the study Pregnancy and breastfeeding Not being able to provide written informed consent to participate in the study or to cooperate and comply with the study procedures for any other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre, randomized, double-blind clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPL-1 Probiotic capsules<br>BPL-1 Probiotic 1 capsule/day | Dietary Supplement: BPL-1 Probiotic capsules<br>* BPL-1 Probiotic 1 capsule/day<br>|
| Placebo Comparator: Placebo<br>1 capsule/day | Dietary Supplement: Placebo<br>* Placebo masked with the same presentation as the experimental product 1 capsule/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Fasting glucose | 12 weeks | 
| Glycated haemoglobin | Glycated haemoglobin | 12 weeks | 
| Insulin | Insulin | 12 weeks | 
| HOMA-IR | HOMA-IR | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Total cholesterol | 12 weeks | 
| HDL-cholesterol | HDL-cholesterol | 12 weeks | 
| LDL-cholesterol | LDL-cholesterol | 12 weeks | 
| Triglycerides | Triglycerides | 12 weeks | 
| Body Mass Index (BMI) | Body Mass Index (BMI) | 12 weeks | 
| Body Fat Percentage (%BF) | Body Fat Percentage (%BF) | 12 weeks | 
| Blood pressure | Blood pressure | 12 weeks | 
| Waist perimeter | Waist perimeter | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Microbiote, Cardiovascular Risk