NCT07609992Completed
The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus
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"
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 15 May 2026
- Start date
- 1 Jun 2023
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- Pirogov Russian National Research Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07609992
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Jun 2023 to the primary completion date, 30 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antidiabetic drugs other than metformin, DPP-4 inhibitors or SGLT2 inhibitors
Other illness
- Intestinal diseases (ulcerative colitis, Crohn's disease, etc.)
- AIDS/HIV
Other
- Pregnancy
- The use of other dietary fibers.
- Participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial.
Who the study is looking for
- 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.
Age in the registry: 45 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| State clinical hospital named after V.P. Demikhov Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.