Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice

NCT07252765 | Recruiting DMC

• 1 other identifier: NES-2024-252-DiabetPlus
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 12

Brief Summary

The objective of this observational study is to characterize the patient profile and nutritional treatment patterns of individuals with type 2 diabetes (T2D) or drug-induced diabetes who present with malnutrition, or are at risk of it, and who are prescribed a diabetes-specific oral nutritional supplement (ONS) that is high in calories and protein and contains soluble fiber. Participants will complete a series of questionnaires during visits 1 and 3.

Conditions

Type 2 Diabetes Mellitus (T2DM); Malnutrition; Malnourishment; Drug-Induced Diabetes

Keywords

Metabolic control; Disease - realted malnutrition; Diabetes-specific formula; T2D; Oral nutritional supplementation; Type 2 Diabetes Mellitus; Malnourishment; Malnutrition; Drug-induced diabetes

Outcome Measures

Primary Outcomes (1)

• Descriptive of study population

  Descriptive information of the population at V1

  Baseline visit (V1)

Secondary Outcomes (14)

• Percentage change of blood test parameters

  From enrollment to end of treatment at 24 weeks

• Percentage of patients with improvement in the nutritional status

  From enrollment to end of treatment at 24 weeks

• Associated cost at 6-month follow-up

  From enrollment to end of treatment at 24 weeks

• Adherence with prescribed oral nutritional supplement (ONS)

  From enrollment to end of treatment at 24 weeks

• Change in functional status of participants over time

  From enrollment to end of treatment at 24 weeks

Other Outcomes (1)

• Nutritional status at molecular level

  From enrollment to end of treatment at 24 weeks

Study Arms (1)

Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Outcomes'10: lead
• Nestlé Health Science Spain: collaborator

Study Sites (12)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, 21005, Spain

RECRUITING

Hospital UniversitarioDoctor Negrín

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

RECRUITING

Hospital La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Virgen de la Victoria

Málaga, Malaga, 29010, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41005, Spain

RECRUITING

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, 41009, Spain

RECRUITING

Hospital La Fe

Valencia, Valencia, 460026, Spain

RECRUITING

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Malnutrition

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders

Central Study Contacts

Mercedes Blanco Naveira, Medical Adviser. MD

CONTACT

+34 628 237 634; mercedes.blanco@es.nestle.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: November 28, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)