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

Pirogov Russian National Research Medical University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes (T2DM)

Interventions

The main (study) group will include patients who are additionally prescribed dietary fiber supplements Optifiber (regimen of use from 1 to 3 days - 1 sachet per day (5 g) - lunch, from 4 to 6 days - 2 sachets per day (10 g) - lunch + dinner, from 7 to 90 ± 2 days - 3 sachets per day (15 g))

Eligibility

Sex: ALLMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus; * The duration of the disease is less than 5 years; * Age from 45 to 60 years; * HbA1c up to 7.5%; * Body mass index from 27 to 35 kg/m2; * Patients who were assigned flash monitoring to control carbohydrate metabolism and complex therapy as part of routine clinical practice; * Voluntary informed consent to participate in the study. Exclusion Criteria: * Use of antidiabetic drugs other than metformin, DPP-4 inhibitors or SGLT2 inhibitors * Intestinal diseases (ulcerative colitis, Crohn's disease, etc.) * Pregnancy * AIDS/HIV * The use of other dietary fibers. * Participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial.

Locations (1)

State clinical hospital named after V.P. Demikhov

Moscow, Russia

Outcomes

Primary Outcomes

Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months

Time frame: 84 days

Data from ClinicalTrials.gov

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