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New study tracks how doctors treat malnutrition in diabetes patients

NCT ID NCT07252765

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study follows 334 adults with type 2 diabetes or drug-induced diabetes who are malnourished or at risk. Researchers will track their nutritional treatment patterns after being prescribed a special high-calorie, high-protein supplement with fiber. Participants fill out questionnaires at two visits over six months, and the study aims to describe patient profiles and changes in health measures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diabetes-specific oral nutritional supplement (high-calorie, high-protein, with soluble fiber)
What this could lead to
If successful, this study could help doctors better understand how to manage malnutrition in people with type 2 diabetes, potentially improving care guidelines.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by other factors and may not apply to all patients.

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.

Participants

About 334 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Patients diagnosed with type 2 diabetes (T2D) or drug-induced diabetes, at nutritional risk according to MUST and/or presenting malnutrition according to GLIM criteria, who require a diabetes-specific oral nutritional supplement (ONS) that is high-calorie, high-protein, and contains soluble fiber, and who have been prescribed such an ONS in real-world clinical practice within the previous 7 days

Ages

18 years and older

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: * Adult patients diagnosed with type 2 diabetes (T2D) or drug-induced diabetes * Patients at nutritional risk according to MUST or presenting malnutrition according to GLIM criteria. * Patients requiring a diabetes-specific oral nutritional supplement (ONS) that is high-calorie, high-protein, and contains soluble fiber in real-world clinical practice, and who have been prescribed such a supplement within the previous 7 days. * Patients able to provide informed consent and complete the study questionnaires. Exclusion Criteria: * Patients participating in other studies or clinical trials related to malnutrition, or who, in the investigator's opinion, may alter the course of the study. * Patients currently receiving or expected to receive other types of nutritional interventions involving supplements (oral or otherwise) or non-conventional feeding methods (e.g., feeding tubes). * Patients with a history of metabolic/endocrine diseases (other than diabetes) or any other condition causing liver or kidney failure, defined as ALT \> 3x ULN or eGFR \< 30 ml/min/1.73 m², and according to the investigator's judgment. * Patients expected to undergo any surgical intervention or require hospitalization due to a condition unrelated to the study during the study period. * Patients with other conditions that, in the investigator's opinion, may interfere with adherence to the intervention or with study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital General de Valencia

    RECRUITING

    Valencia, Valencia, 46014, Spain

  • Hospital La Fe

    RECRUITING

    Valencia, Valencia, 460026, Spain

  • Hospital La Princesa

    RECRUITING

    Madrid, Madrid, 28006, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Juan Ramón Jiménez

    RECRUITING

    Huelva, Huelva, 21005, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen de la Macarena

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Sevilla, 41005, Spain

  • Hospital UniversitarioDoctor Negrín

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Hospital Virgen de la Victoria

    RECRUITING

    Málaga, Malaga, 29010, Spain

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