NCT07252765 Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice
| NCT ID | NCT07252765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Outcomes'10 |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 334 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-10 |
Trial Parameters
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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.
Eligibility Criteria
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
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