Status:
COMPLETED
Effect of Probiotic on Insulin Resistance in Type 2 Diabetes Patients
Lead Sponsor:
Bogomolets National Medical University
Conditions:
Type2 Diabetes
Insulin Resistance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Probiotics have beneficial effect on obesity related disorders in animal models. Despite a large number of animal data, randomized placebo-controlled trials (RCT) concluded that probiotics have a mode...
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...
Eligibility Criteria
Inclusion
- adult participants (ages 18-75, BMI ≥25 kg/m2) diagnosed with T2D according WHO (1999) for 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-IR≥2.0;
- HbA1c between 6.5 and 11.0 %;
- written informed consent.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
January 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03434860
Start Date
January 15 2016
End Date
January 25 2017
Last Update
December 17 2019
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