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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191525
Recruitment Status : Completed
First Posted : December 9, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mónica Marazuela Azpíroz, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, randomized, double-blind clinical trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
1 capsule/day
Dietary Supplement: Placebo
Placebo masked with the same presentation as the experimental product 1 capsule/day




Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: 12 weeks ]
    Fasting glucose

  2. Glycated haemoglobin [ Time Frame: 12 weeks ]
    Glycated haemoglobin

  3. Insulin [ Time Frame: 12 weeks ]
    Insulin

  4. HOMA-IR [ Time Frame: 12 weeks ]
    HOMA-IR


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol

  2. HDL-cholesterol [ Time Frame: 12 weeks ]
    HDL-cholesterol

  3. LDL-cholesterol [ Time Frame: 12 weeks ]
    LDL-cholesterol

  4. Triglycerides [ Time Frame: 12 weeks ]
    Triglycerides

  5. Body Mass Index (BMI) [ Time Frame: 12 weeks ]
    Body Mass Index (BMI)

  6. Body Fat Percentage (%BF) [ Time Frame: 12 weeks ]
    Body Fat Percentage (%BF)

  7. Blood pressure [ Time Frame: 12 weeks ]
    Blood pressure

  8. Waist perimeter [ Time Frame: 12 weeks ]
    Waist perimeter


Other Outcome Measures:
  1. Mediterranean diet adherence score [ Time Frame: 12 weeks ]
    Mediterranean diet adherence score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Universitario de La princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Mónica Marazuela Azpíroz
Investigators
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Principal Investigator: Mónica Marazuela Azpíroz, MD PhD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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Responsible Party: Mónica Marazuela Azpíroz, Head of Endocrinology and Nutrition, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT04191525    
Other Study ID Numbers: PROBIDEM
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mónica Marazuela Azpíroz, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Diabetes Mellitus
Microbiote
Cardiovascular Risk
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases