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Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes

Primary Purpose

Type2 Diabetes, Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Bogomolets National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring probiotics; type 2 diabetes; pancreatic β-cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult participants (aged 18 to 75); presence of T2D diagnosis based on the criteria of the American Diabetes Association (plasma glucose in fasting state ≥7.0 mmol/l; plasma glucose at random measuring ≥11.1 mmol/l; HbA1c ≥6.5% or glucose > 11.1 mmol/l 2 hours after tolerance test with 75 g of glucose); presence of pancreatic β-cell dysfunction which defined as HOMA2-β<50%; treatment with insulin therapy alone or in combination with oral anti-diabetic drugs (metformin and/or sulphonylureas) in a stable dose for at least 3 months prior to randomization; HbA1c level 6.5 to 11.0%; signed informed consent Exclusion Criteria: presence of T1D; intake of anti-diabetic drugs except for those specified in the inclusion criteria (pioglitazone, glucagon-like peptide (GLP-1) analogs, dipeptide-peptidase 4 (DPP-4) inhibitors, etc.); severe diabetes-related complications at screening (ie, end-stage diabetic kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy); regular intake of probiotics, prebiotics or antibiotics for 3 months prior the inclusion; previously diagnosed allergy to probiotics; gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis; an uncontrolled cardiovascular or respiratory disease, an active malignant tumor or chronic infections; participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment; participation in another clinical trial; pregnancy or lactation.

Sites / Locations

  • Bogomolets National Medical University
  • Kyiv City Clinical Endocrinology Center
  • Taras Shevchenko National University of Kyiv
  • Danylo Halytsky Lviv National Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

probiotic

placebo

Arm Description

The multiprobiotic which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic per day.

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day

Outcomes

Primary Outcome Measures

β-cell function (%B)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
C-peptide
C-peptide, ng/ml

Secondary Outcome Measures

HOMA-2IR
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
insulin sensitivity (%S)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
HbA1c
HbA1c in %
fasting plasma glucose (FPG)
FPG in mmol/L
weight
weight in kg
waist circumferences (WC)
WC in cm
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m^2
cytokines levels
TNF-α, IL-1β, IL-6, IL-8, INF-γ

Full Information

First Posted
March 1, 2023
Last Updated
March 10, 2023
Sponsor
Bogomolets National Medical University
Collaborators
Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Kyiv City Clinical Endocrinology Center
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1. Study Identification

Unique Protocol Identification Number
NCT05765292
Brief Title
Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes
Official Title
Efficacy and Safety of Multi-strain Probiotic on Pancreatic β-cell Function in Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bogomolets National Medical University
Collaborators
Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Kyiv City Clinical Endocrinology Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Probiotics have beneficial effect on obesity related disorders in animal models. Current understanding for the beneficial effects of probiotics in type 2 diabetes strictly relies on animal and clinical data, which mainly focus on their impact on insulin resistance, anthropometric parameters, glycemic control and markers of chronic systemic inflammation. From the other hand, there is a lack of evidence-based probiotic efficacy on pancreatic β-cell function in terms of type 2 diabetes and related metabolic disorders. In this double-blind single center randomized clinical trial, effect of alive multistrain probiotic vs. placebo on pancreatic β-cell function in type 2 diabetes patient will be assessed.
Detailed Description
In this single-center double blind, placebo controlled, parallel group study, type 2 diabetes patients from the Kyiv City Clinical Endocrinology Center will be selected. They will be randomly assigned to receive multiprobiotic "Symbiter" or placebo for 8-weeks administered as a sachet formulation in double-blind treatment. Randomization will be done by the study statistician based on a computer-generated list. The groups will be homogeneous according to age, sex and diagnostic criteria. The assignment of groups will be blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention. The multiprobiotic "Symbiter" will be supplied by Scientific and Production Company "O.D. Prolisok". It contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic and placebo per day. All sachets were identical with similar organoleptic characteristics (e.g., taste and appearance). The pre-randomization period designed to minimize the effects of dietary changes on metabolic markers. For this purpose, 2 weeks before the study start, after inform consent signed, patients will be instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP. In addition, participants will be instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day. Patients who underwent study will be instructed to take the trial medication as prescribed. Throughout the study, weekly phone follow-up visits will be provided for assessment of compliance, adherence to the protocol, as well as the recording of adverse events. The effectiveness of therapy will be compared and evaluated separately in the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Obesity, Insulin Resistance, Obesity, Abdominal
Keywords
probiotics; type 2 diabetes; pancreatic β-cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic
Arm Type
Active Comparator
Arm Description
The multiprobiotic which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic per day.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Symbiter
Intervention Description
The multiprobiotic which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the pa
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
Primary Outcome Measure Information:
Title
β-cell function (%B)
Description
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
Time Frame
8 weeks compared to baseline
Title
C-peptide
Description
C-peptide, ng/ml
Time Frame
8 weeks compared to baseline
Secondary Outcome Measure Information:
Title
HOMA-2IR
Description
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
Time Frame
8 weeks compared to baseline
Title
insulin sensitivity (%S)
Description
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
Time Frame
8 weeks compared to baseline
Title
HbA1c
Description
HbA1c in %
Time Frame
8 weeks compared to baseline
Title
fasting plasma glucose (FPG)
Description
FPG in mmol/L
Time Frame
8 weeks compared to baseline
Title
weight
Description
weight in kg
Time Frame
8 weeks compared to baseline
Title
waist circumferences (WC)
Description
WC in cm
Time Frame
8 weeks compared to baseline
Title
body mass index (BMI)
Description
weight in kg and height in meters will be combined to report BMI in kg/m^2
Time Frame
8 weeks compared to baseline
Title
cytokines levels
Description
TNF-α, IL-1β, IL-6, IL-8, INF-γ
Time Frame
8 weeks compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult participants (aged 18 to 75); presence of T2D diagnosis based on the criteria of the American Diabetes Association (plasma glucose in fasting state ≥7.0 mmol/l; plasma glucose at random measuring ≥11.1 mmol/l; HbA1c ≥6.5% or glucose > 11.1 mmol/l 2 hours after tolerance test with 75 g of glucose); presence of pancreatic β-cell dysfunction which defined as HOMA2-β<50%; treatment with insulin therapy alone or in combination with oral anti-diabetic drugs (metformin and/or sulphonylureas) in a stable dose for at least 3 months prior to randomization; HbA1c level 6.5 to 11.0%; signed informed consent Exclusion Criteria: presence of T1D; intake of anti-diabetic drugs except for those specified in the inclusion criteria (pioglitazone, glucagon-like peptide (GLP-1) analogs, dipeptide-peptidase 4 (DPP-4) inhibitors, etc.); severe diabetes-related complications at screening (ie, end-stage diabetic kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy); regular intake of probiotics, prebiotics or antibiotics for 3 months prior the inclusion; previously diagnosed allergy to probiotics; gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis; an uncontrolled cardiovascular or respiratory disease, an active malignant tumor or chronic infections; participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment; participation in another clinical trial; pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazarii Kobyliak
Organizational Affiliation
Bogomolets National Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bogomolets National Medical University
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Kyiv City Clinical Endocrinology Center
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Taras Shevchenko National University of Kyiv
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Danylo Halytsky Lviv National Medical University
City
Lviv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes

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