Status:
COMPLETED
Smectite Gel and Probiotic for Obesity and Insulin Resistance
Lead Sponsor:
Bogomolets National Medical University
Collaborating Sponsors:
Taras Shevchenko National University of Kyiv
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Smectite is a natural silicate clay belonging to the dioctahedral smecti...
Detailed Description
In this single-center double-blind, placebo controlled, parallel group study, 55 type 2 diabetes patients from the Kyiv City Clinical Endocrinology Center were selected. They were randomly assigned to...
Eligibility Criteria
Inclusion
- adult participants (ages 18-75, BMI ≥25 kg/m2)
- presence of type 2 diabetes 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);
- type 2 diabetes 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
- 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.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04293731
Start Date
November 1 2018
End Date
May 28 2019
Last Update
June 15 2023
Active Locations (1)
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1
Bogomolets National Medical University
Kyiv, Ukraine, 01601