Nutritional care for adults with type 2 or drug-induced diabetes who are malnourished or at risk
Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice. STARLIGHT Study
This observational study will follow adults with type 2 or drug-induced diabetes who are malnourished or at risk to see if taking a diabetes-specific high-calorie, high-protein oral supplement with soluble fiber helps their nutrition, blood sugar, and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Outcomes'10 Research network |
| Locations | 12 sites (Santander, Cantabria and 11 other locations) |
| Trial ID | NCT07252765 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective real-world study across 12 hospitals in Spain enrolling adults with type 2 or drug-induced diabetes who are malnourished or at nutritional risk and have been recently prescribed a diabetes-specific oral nutritional supplement (high-calorie, high-protein, with soluble fiber). Clinical, metabolic, nutritional, functional and healthcare resource-use data are collected at baseline and follow-up visits over a six-month period, with patients completing questionnaires at visit 1 and visit 3. Secondary outcomes include changes in glycemic/metabolic control, nutritional and functional status, adherence and satisfaction with the supplement, quality of life, and associated costs. An exploratory objective uses nutritional ultrasound to estimate changes in muscle mass.
Who should consider this trial
Good fit: Adults with type 2 diabetes or drug-induced diabetes who meet MUST or GLIM criteria for malnutrition or are at nutritional risk and who were prescribed a diabetes-specific high-calorie, high-protein oral supplement with soluble fiber within the past seven days are ideal candidates.
Not a fit: Patients already receiving other nutritional interventions (including enteral feeding), those with other uncontrolled metabolic or endocrine diseases beyond diabetes, or those unable to adhere to the supplement regimen are unlikely to derive benefit from this observational protocol.
Why it matters
Potential benefit: If successful, this work could support use of diabetes-specific oral supplements to improve nutritional status, preserve muscle, stabilize blood sugar, and reduce complications and healthcare use in people with type 2 diabetes and malnutrition.
How similar studies have performed: Prior small trials and observational studies suggest diabetes-specific oral nutritional supplements can improve nutritional markers and are generally tolerated without major worsening of glycemic control, but overall real-world evidence is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Santander, Cantabria and 11 other locations
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario Juan Ramón Jiménez — Huelva, Huelva, Spain (Recruiting)
- Hospital UniversitarioDoctor Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital La Princesa — Madrid, Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
- Hospital Virgen de la Victoria — Málaga, Malaga, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Sevilla, Spain (Recruiting)
- Hospital Universitario Virgen de la Macarena — Seville, Sevilla, Spain (Recruiting)
- Hospital La Fe — Valencia, Valencia, Spain (Recruiting)
- Hospital General de Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Mercedes Blanco Naveira, Medical Adviser. MD
- Email: mercedes.blanco@es.nestle.com
- Phone: +34 628 237 634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.