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
This trial does not accept healthy volunteersQualifiers
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 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
334 Participants
are grouped into 1 trial groupGroup A: Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it
Trial outcomes
Primary outcomes
1
Descriptive of study population
Descriptive information of the population at V1
Time frame
Baseline visit (V1)Secondary outcomes
1
Percentage change of blood test parameters
Changes in blood test measures will be compared
Time frame
From enrollment to end of treatment at 24 weeks2
Percentage of patients with improvement in the nutritional status
Changes in GLIM or MUST classifications
Time frame
From enrollment to end of treatment at 24 weeks3
Associated cost at 6-month follow-up
They will be estimated by multiplying the number of units used by their unit cost (derived from eSalud and Botplus databases). Unit: Number of events; euros (€)
Time frame
From enrollment to end of treatment at 24 weeks4
Adherence with prescribed oral nutritional supplement (ONS)
Participants will be categorized as compliant (≥80% consumption) or non-compliant (\<80%).
Time frame
From enrollment to end of treatment at 24 weeksOther outcomes
1
Nutritional status at molecular level
Test: nutritional (morphofunctional) ecography
Time frame
From enrollment to end of treatment at 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Outcomes'10
Lead sponsor
Nestlé Health Science Spain
Collaborator
Source ClinicalTrials.gov