NCT07252765

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 334 (estimated)
• Sponsor: Outcomes'10 · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Malnutrition
• Malnourishment
• Drug-Induced Diabetes

Timeline

• Start date: 2025-11-20
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-11-28
• Last updated: 2026-01-28

Locations

12 sites across 1 country: Spain