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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: BPL-1 Probiotic capsules; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediterranean diet adherence score	Mediterranean diet adherence score	12 weeks

Collaborators and Investigators

• Sponsor: Mónica Marazuela Azpíroz
• Collaborators: Alba Garcimartín Álvarez; Carolina Knott Torcal; Nerea Aguirre Moreno; Miguel Antonio Sampedro Núñez; María Caldas; Belén Ruiz-Rosso; Ana María Ramos Levi
• Investigators: Principal Investigator: Mónica Marazuela Azpíroz, MD PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Cardiovascular Risk; Microbiote
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PROBIDEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No