Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice
Recruiting · NCT07252765 · Observational (researchers observe without assigning treatment) · Lead sponsor: Outcomes'10
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
12 locations listed.
- Hospital Universitario Marqués de Valdecilla - Santander, Cantabria, Spain
- Hospital Universitario Juan Ramón Jiménez - Huelva, Huelva, Spain
- Hospital UniversitarioDoctor Negrín - Las Palmas de Gran Canaria, Las Palmas, Spain
- Hospital La Princesa - Madrid, Madrid, Spain
- Hospital Clínico San Carlos - Madrid, Madrid, Spain
- Hospital Universitario La Paz - Madrid, Madrid, Spain
- Hospital Virgen de la Victoria - Málaga, Malaga, Spain
- Hospital Universitario Central de Asturias - Oviedo, Principality of Asturias, Spain
- Hospital Universitario Virgen del Rocío - Seville, Sevilla, Spain
- Hospital Universitario Virgen de la Macarena - Seville, Sevilla, Spain
- Hospital La Fe - Valencia, Valencia, Spain
- Hospital General de Valencia - Valencia, Valencia, Spain