Prospective-retrospective Observational Minimal Intervention Study "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 University1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2023年6月1日最近更新: 2026年5月27日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 80
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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:

To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus.
To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus.
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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 45 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Use of antidiabetic drugs other than metformin, DPP-4 inhibitors or SGLT2 inhibitors
•Intestinal diseases (ulcerative colitis, Crohn's disease, etc.)
•Pregnancy
•The use of other dietary fibers.
•Participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial.

研究者

发起方

Pirogov Russian National Research Medical University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Demidova Tatiana Yulievna

Ph.D., Professor. Head of the department of endocrinology, Institute of clinical medicine

Pirogov Russian National Research Medical University

研究点 (1)

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