Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOutcomes'10
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
334 Participants
are grouped into 1 trial groupSponsors and collaborators
Outcomes'10
Lead sponsor
Nestlé Health Science Spain
Collaborator
Source ClinicalTrials.gov