Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)
Obesity, Obesity, Abdominal, Insulin Resistance
About this trial
This is an interventional treatment trial for Obesity focused on measuring Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Type2 Diabetes, Insulin Resistance
Eligibility Criteria
Inclusion Criteria: adult participants (ages 18-70) presence of T2D diagnosed according to criteria of the American Diabetes Association; BMI 25-40 kg/m2; patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study; daily insulin dosage less than 60IU; HbA1c between 6.5 and 10.0 %; written informed consent. Exclusion Criteria: presence of type 1 diabetes; severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy); treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, SGLT-2 antagonists, GLP-1 analogues, DPP IV inhibitors etc); regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment; allergy on probiotics or their components; presence of gastrointestinal diseases such as food allergy, celiac disease, non-specific ulcerative colitis; uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, 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 other clinical trials; presence of pregnancy or lactation.
Sites / Locations
- Bogomolets National Medical UniversityRecruiting
- Kyiv City Clinical Endocrinology CenterRecruiting
- Center for Innovative Medical Technologies of the National Academy of Sciences of UkraineRecruiting
- Danylo Halytsky Lviv National Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Probiotic lysate (postbiotic and metabiotic) group
Placebo group
oral, 2 capsules per day (BID) for 3 month treatment
placebo, oral, 2 capsules per day (BID) for 3 month treatment