Probiotic With Omega-3 Fatty Acids on Obesity and Insulin Resistance Management in Patients With Type 2 Diabetes

ENDO-5

Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Omega-3 fatty acids belong to the family of polyunsaturated fatty acids. They are known to exert a strong positive influence on metabolism and inflammation. The data from animal studies suggested that both probiotics and omega-3 can affect body weight, influence on glucose and fat metabolism, improve insulin sensitivity and reduce chronic systemic inflammation. In respect to experimental data, the current study aim was to provide double-blind single center RCT, for study the efficacy of co-administration of probiotic with omega-3 vs. placebo in type 2 diabetes patient

2018-02-01

2018-03-01

2019-01-15

Completed

56

Inclusion Criteria: * adult participants (ages 18-75, BMI ≥25 kg/m2) * presence of T2D diagnosed according to criteria of the American Diabetes Association (fasting plasma glucose (FPG)≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%, or glucose higher than 11.1mmol/l 2 hours after a 75-g oral glucose load); * T2D duration at least 6 months prior to the study; * 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; * presence of insulin resistance established as HOMA-2IR≥2.0; * HbA1c between 6.5 and 11.0 %; * written informed consent. Exclusion Criteria: * presence of type 1 diabetes; * treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, GLP-1 analogues, DPP IV inhibitors etc); * regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment; antibiotic use 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; * participation in other clinical trials; * presence of pregnancy or lactation.

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2023-06-15