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Recruiting NCT07252765

NCT07252765 Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice

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Clinical Trial Summary
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

Condition Type 2 Diabetes Mellitus (T2DM)
Sponsor Outcomes'10
Study Type OBSERVATIONAL
Phase N/A
Enrollment 334
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-20
Completion 2026-10

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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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