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

Outcomes'10

Status: Enrolling

Conditions: Malnourishment; Malnutrition; Type 2 Diabetes Mellitus (T2DM); Drug-Induced Diabetes

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT07252765

NES-2024-252-DiabetPlus

Details and patient eligibility

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.

Full description

1. Background and Rationale This study focuses on patients with type 2 diabetes mellitus (T2D) who also present with malnutrition or are at risk of developing malnutrition. These conditions negatively affect clinical and functional outcomes, increasing the likelihood of complications and hospitalizations. The use of diabetes-specific oral nutritional supplements (ONS)-characterized by a high caloric and protein content and enriched with soluble fiber-may contribute to improving clinical status, nutritional parameters, and quality of life. Nevertheless, current evidence from real-world clinical practice remains limited and heterogeneous.

2. Primary Objective To characterize the clinical and nutritional profile, as well as the nutritional treatment patterns, of patients with T2D and malnutrition or at risk of malnutrition who are prescribed a diabetes-specific ONS.

3. Secondary Objectives

   To assess changes in glycemic and metabolic control.

   To evaluate the nutritional and functional impact of the ONS.

   To analyze healthcare resource utilization and associated costs.

   To estimate patient adherence, compliance, and satisfaction with the prescribed ONS.

   To assess quality-of-life outcomes over a 6-month follow-up period.

4. Exploratory Objective To explore changes in muscle mass using nutritional ultrasound.

5. Study Design

   Multicenter, prospective, real-world evidence (RWE) study.

   Conducted across 12 hospitals in Spain.

   Three scheduled visits: baseline (V1), 3-month follow-up (V2), and 6-month final visit (V3).

6. Study Population A total of 334 adult patients with T2D and either nutritional risk or malnutrition, all of whom are prescribed a diabetes-specific ONS.

7. Collected Variables

   Sociodemographic: age, sex, education level, etc.

   Clinical and anthropometric: weight, muscle mass, comorbidities.

   ONS-related: product name, dosage, duration, modifications, palatability.

   Nutritional requirements: daily caloric, protein, fat, and carbohydrate needs.

   Healthcare resource utilization: hospital admissions, emergency visits, specialist consultations, and diabetes medication adjustments.

   Metabolic profile: HbA1c, fasting glucose, lipid panel, albumin, total protein, hemoglobin, liver enzymes, eGFR, and CRP.

   Functional assessment: SARC-F scale, handgrip strength, bioelectrical impedance analysis (BIA), nutritional ultrasound, and Timed Up and Go test.

   Patient-reported outcomes: NutriQoL® quality-of-life questionnaire, satisfaction survey, treatment adherence questionnaire, and ONS palatability scale.

8. Data Management and Analysis Data will be managed by Outcomes'10 and analyzed using STATA v.14. Descriptive and comparative analyses will be conducted to address the primary and secondary objectives. All data will be reviewed and pseudonymized to ensure patient confidentiality.

Enrollment: 334 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

334 participants in 1 patient group

Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it