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Fiber fix? new study tests OptiFibre for diabetes control

NCT ID NCT07609992

Disease control Sponsor: Pirogov Russian National Research Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a dietary fiber called OptiFibre can help people with type 2 diabetes control their blood sugar and lose weight. About 80 adults with diabetes were observed for 3 months. The goal was to see if adding this fiber to their routine improved blood sugar levels, cholesterol, and gut health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes (T2DM)

Contacts and locations

Locations

  • State clinical hospital named after V.P. Demikhov

    Moscow, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.