Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04191525|
Recruitment Status : Completed
First Posted : December 9, 2019
Last Update Posted : December 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Dietary Supplement: BPL-1 Probiotic capsules Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-centre, randomized, double-blind clinical trial|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||September 10, 2018|
|Actual Primary Completion Date :||June 26, 2019|
|Actual Study Completion Date :||June 26, 2019|
Experimental: BPL-1 Probiotic capsules
BPL-1 Probiotic 1 capsule/day
Dietary Supplement: BPL-1 Probiotic capsules
BPL-1 Probiotic 1 capsule/day
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Placebo masked with the same presentation as the experimental product 1 capsule/day
- Fasting glucose [ Time Frame: 12 weeks ]Fasting glucose
- Glycated haemoglobin [ Time Frame: 12 weeks ]Glycated haemoglobin
- Insulin [ Time Frame: 12 weeks ]Insulin
- HOMA-IR [ Time Frame: 12 weeks ]HOMA-IR
- Total cholesterol [ Time Frame: 12 weeks ]Total cholesterol
- HDL-cholesterol [ Time Frame: 12 weeks ]HDL-cholesterol
- LDL-cholesterol [ Time Frame: 12 weeks ]LDL-cholesterol
- Triglycerides [ Time Frame: 12 weeks ]Triglycerides
- Body Mass Index (BMI) [ Time Frame: 12 weeks ]Body Mass Index (BMI)
- Body Fat Percentage (%BF) [ Time Frame: 12 weeks ]Body Fat Percentage (%BF)
- Blood pressure [ Time Frame: 12 weeks ]Blood pressure
- Waist perimeter [ Time Frame: 12 weeks ]Waist perimeter
- Mediterranean diet adherence score [ Time Frame: 12 weeks ]Mediterranean diet adherence score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191525
|Hospital Universitario de La princesa|
|Madrid, Spain, 28006|
|Principal Investigator:||Mónica Marazuela Azpíroz, MD PhD||Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|