Clinical Trial

The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus

Completed
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Summary
The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are: 1. To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus. 2. To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus. 3. To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus. 4. To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus. The observational study is planned to include approximately 80 patients diagnosed with type 2 diabetes mellitus, with 40 patients divided into the main and control groups. In the control group, the necessary information will be collected retrospectively using archived patient data. In the main (study) group, data will be collected prospectively.
Trial Details
NCT Number NCT07609992
Lead Sponsor Pirogov Russian National Research Medical University
Conditions Type 2 Diabetes (T2DM)
Enrollment 80 participants
Start Date 2023-06-01
Primary Completion 2024-03-30 (estimated)
Study Completion 2024-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-27