Nutritional care for adults with type 2 or drug-induced diabetes who are malnourished or at risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective real-world study across 12 hospitals in Spain enrolling adults with type 2 or drug-induced diabetes who are malnourished or at nutritional risk and have been recently prescribed a diabetes-specific oral nutritional supplement (high-calorie, high-protein, with soluble fiber). Clinical, metabolic, nutritional, functional and healthcare resource-use data are collected at baseline and follow-up visits over a six-month period, with patients completing questionnaires at visit 1 and visit 3. Secondary outcomes include changes in glycemic/metabolic control, nutritional and functional status, adherence and satisfaction with the supplement, quality of life, and associated costs. An exploratory objective uses nutritional ultrasound to estimate changes in muscle mass.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Marqués de Valdecilla
  Santander, Cantabria, Spain Recruiting
• Hospital Universitario Juan Ramón Jiménez
  Huelva, Huelva, Spain Recruiting
• Hospital UniversitarioDoctor Negrín
  Las Palmas de Gran Canaria, Las Palmas, Spain Recruiting
• Hospital La Princesa
  Madrid, Madrid, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario La Paz
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Mercedes Blanco Naveira, Medical Adviser. MD
• Email: mercedes.blanco@es.nestle.com
• Phone: +34 628 237 634

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.