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

NCT05765292 | Completed

• 1 other identifier: ENDO-8
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

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.

Conditions

Type2 Diabetes; Obesity; Insulin Resistance; Obesity, Abdominal

Keywords

probiotics; type 2 diabetes; pancreatic β-cells

Outcome Measures

Primary Outcomes (2)

• 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

  8 weeks compared to baseline

• C-peptide

  C-peptide, ng/ml

  8 weeks compared to baseline

Secondary Outcomes (8)

• HOMA-2IR

  8 weeks compared to baseline

• insulin sensitivity (%S)

  8 weeks compared to baseline

• HbA1c

  8 weeks compared to baseline

• fasting plasma glucose (FPG)

  8 weeks compared to baseline

• weight

  8 weeks compared to baseline

Study Arms (2)

probiotic

ACTIVE COMPARATOR

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.

Dietary Supplement: Probiotic

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Also known as: Symbiter

probiotic

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of T1D;
• severe diabetes-related complications at screening (ie, end-stage diabetic kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
• 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.

Sponsors & Collaborators

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

Study Sites (4)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Kyiv City Clinical Endocrinology Center

Kyiv, 01601, Ukraine

Location

Taras Shevchenko National University of Kyiv

Kyiv, 01601, Ukraine

Location

Danylo Halytsky Lviv National Medical University

Lviv, Ukraine

Location

Related Publications (1)

• Savytska M, Kyriienko D, Komisarenko I, Kovalchuk O, Falalyeyeva T, Kobyliak N. Probiotic for Pancreatic beta-Cell Function in Type 2 Diabetes: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Diabetes Ther. 2023 Nov;14(11):1915-1931. doi: 10.1007/s13300-023-01474-6. Epub 2023 Sep 15.

  PMID: 37713103 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance; Obesity, Abdominal; Diabetes Mellitus, Type 2

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nazarii Kobyliak

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology Department

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 15, 2021
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (4)