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

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 334

Contacts and Locations

• Study Contact: Name: Mercedes Blanco Naveira, Medical Adviser. MD; Phone Number: +34 628 237 634; Email: mercedes.blanco@es.nestle.com

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marqués de Valdecilla
  • Huelva
    • Huelva, Huelva, Spain, 21005
      • Recruiting
      • Hospital Universitario Juan Ramon Jimenez
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Recruiting
      • Hospital UniversitarioDoctor Negrín
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Clinico San Carlos
    • Madrid, Madrid, Spain, 28046
      • Recruiting
      • Hospital Universitario La Paz
    • Madrid, Madrid, Spain, 28006
      • Recruiting
      • Hospital La Princesa
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Recruiting
      • Hospital Virgen de la Victoria
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
  • Sevilla
    • Seville, Sevilla, Spain, 41005
      • Recruiting
      • Hospital Universitario Virgen del Rocio
    • Seville, Sevilla, Spain, 41009
      • Recruiting
      • Hospital Universitario Virgen de la Macarena
  • Valencia
    • Valencia, Valencia, Spain, 46014
      • Recruiting
      • Hospital General de Valencia
    • Valencia, Valencia, Spain, 460026
      • Recruiting
      • Hospital la Fé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive of study population	Descriptive information of the population at V1	Baseline visit (V1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change of blood test parameters	Changes in blood test measures will be compared	From enrollment to end of treatment at 24 weeks
Percentage of patients with improvement in the nutritional status	Changes in GLIM or MUST classifications	From enrollment to end of treatment at 24 weeks
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 (€)	From enrollment to end of treatment at 24 weeks
Adherence with prescribed oral nutritional supplement (ONS)	Participants will be categorized as compliant (≥80% consumption) or non-compliant (<80%).	From enrollment to end of treatment at 24 weeks
Change in functional status of participants over time	Changes between visits in SARC-F scale categories	From enrollment to end of treatment at 24 weeks
Change in NutriQoL® quality-of-life score	Patients will be classified according to a quality-of-life category (excellent, good, acceptable, poor, very poor). Test total scoring values.	From enrollment to end of treatment at 24 weeks
Patient satisfaction of the ONS product at 6 months	Responses to the satisfaction questionnaires will be summarized as number and percentage of participants selecting each category at V3.	From enrollment to end of treatment at 24 weeks
Patient palatability of the ONS product at 6 months	Responses to the palatability questionnaires will be summarized as number and percentage of participants selecting each category at V3.	From enrollment to end of treatment at 24 weeks
Health resource use	Frequencies of treatment changes, administration route, specialist consultations, and hospitalizations will be recorded and quantitative variables (treatment dose, treatment duration, number and days of hospitalization, consultations) will be summarized using mean ± SD.	From enrollment to end of treatment at 24 weeks
Change in nutritional status	It will be estimated according to GLIM or MUST classification	From enrollment to end of treatment at 24 weeks
Percentage change in BMI	Weight and height will be combined to report BMI in kg/m2	From enrollment to end of treatment at 24 weeks
Maximum prehensile strenght value	Probe: handgrip test by using a hand dynamometer	From enrollment to end of treatment at 24 weeks
30" chair test	Test: a patient will have to stand-up and sit-down as maximim number of times in 30", from a chair, with both arms crossed in the chest.	From enrollment to end of treatment at 24 weeks
Impedancimetry values	Test: bioimpedance	From enrollment to end of treatment at 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status at molecular level	Test: nutritional (morphofunctional) ecography	From enrollment to end of treatment at 24 weeks

Collaborators and Investigators

• Sponsor: Outcomes'10
• Collaborators: Nestlé Health Science Spain

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Malnutrition; Type 2 Diabetes Mellitus; T2D; Malnourishment; Metabolic control; Oral nutritional supplementation; Diabetes-specific formula; Disease - realted malnutrition; Drug-induced diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Malnutrition; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NES-2024-252-DiabetPlus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No