Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes
Type2 Diabetes, Obesity, Insulin Resistance
About this trial
This is an interventional treatment trial for Type2 Diabetes focused on measuring probiotics; type 2 diabetes; pancreatic β-cells
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.
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
Active Comparator
Placebo Comparator
probiotic
placebo
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