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

NCT04191525 | Completed

• 1 other identifier: PROBIDEM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Microbiote; Cardiovascular Risk

Outcome Measures

Primary Outcomes (4)

• Fasting glucose

  Fasting glucose

  12 weeks

• Glycated haemoglobin

  Glycated haemoglobin

  12 weeks

• Insulin

  Insulin

  12 weeks

• HOMA-IR

  HOMA-IR

  12 weeks

Secondary Outcomes (8)

• Total cholesterol

  12 weeks

• HDL-cholesterol

  12 weeks

• LDL-cholesterol

  12 weeks

• Triglycerides

  12 weeks

• Body Mass Index (BMI)

  12 weeks

Other Outcomes (1)

• Mediterranean diet adherence score

  12 weeks

Study Arms (2)

BPL-1 Probiotic capsules

EXPERIMENTAL

BPL-1 Probiotic 1 capsule/day

Dietary Supplement: BPL-1 Probiotic capsules

Placebo

PLACEBO COMPARATOR

1 capsule/day

Dietary Supplement: Placebo

Interventions

BPL-1 Probiotic capsules DIETARY_SUPPLEMENT

BPL-1 Probiotic 1 capsule/day

BPL-1 Probiotic capsules

Placebo DIETARY_SUPPLEMENT

Placebo masked with the same presentation as the experimental product 1 capsule/day

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mónica Marazuela Azpíroz: lead
• Alba Garcimartín Álvarez: collaborator
• Carolina Knott Torcal: collaborator
• Nerea Aguirre Moreno: collaborator
• Miguel Antonio Sampedro Núñez: collaborator
• María Caldas: collaborator
• Belén Ruiz-Rosso: collaborator
• Ana María Ramos Levi: collaborator

Study Sites (1)

Hospital Universitario de La princesa

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mónica Marazuela Azpíroz, MD PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Endocrinology and Nutrition

Model Details: Single-centre, randomized, double-blind clinical trial

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: September 10, 2018
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)