Type 2 Diabetes Mellitus (T2DM)STARLIGHTNCT07252765
Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice
An observational study of Type 2 Diabetes Mellitus (T2DM) and Malnutrition, run by Outcomes'10 at 12 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Malnutrition, Malnourishment
- How many people
- 334 participants
- Where
- 12 sitesSpain
- Study dates
- 20 Nov 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Spain12 sites, 12 recruiting
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva, Huelva, 21005
- Recruiting
Hospital UniversitarioDoctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
- Recruiting
Hospital La Princesa
Madrid, Madrid, 28006
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
- Recruiting
Hospital Virgen de la Victoria
Málaga, Malaga, 29010
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41005
- Recruiting
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, 41009
- Recruiting
Hospital La Fe
Valencia, Valencia, 460026
- Recruiting
Hospital General de Valencia
Valencia, Valencia, 46014
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- Exploratory Objective To explore changes in muscle mass using nutritional ultrasound.
- 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).
- 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.
- 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.
- 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.
- Keywords
- Metabolic control, Disease - realted malnutrition, Diabetes-specific formula, T2D, Oral nutritional supplementation, Type 2 Diabetes Mellitus, Malnourishment, Malnutrition, Drug-induced diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive of study population
Descriptive information of the population at V1
Measured: Baseline visit (V1)
Secondary outcomes (14)
Percentage change of blood test parameters
Changes in blood test measures will be compared
Measured: From enrollment to end of treatment at 24 weeks
Percentage of patients with improvement in the nutritional status
Changes in GLIM or MUST classifications
Measured: 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 (€)
Measured: 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%).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 24 weeks
Change in nutritional status
It will be estimated according to GLIM or MUST classification
Measured: 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
Measured: From enrollment to end of treatment at 24 weeks
Maximum prehensile strenght value
Probe: handgrip test by using a hand dynamometer
Measured: 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.
Measured: From enrollment to end of treatment at 24 weeks
Impedancimetry values
Test: bioimpedance
Measured: From enrollment to end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Outcomes'10
- Sponsor type
- Research network
- Collaborators
- Nestlé Health Science Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252765
- Sponsor's protocol ID
- NES-2024-252-DiabetPlus
- Acronym
- STARLIGHT
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice. STARLIGHT Study
- ClinicalTrials.gov ID
- NCT07252765
- Acronym / sponsor ID
- STARLIGHT / NES-2024-252-DiabetPlus
- Keywords
- Metabolic control, Disease - realted malnutrition, Diabetes-specific formula, T2D, Oral nutritional supplementation, Type 2 Diabetes Mellitus, Malnourishment, Malnutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Outcomes'10Research network
- Collaborators
- Nestlé Health Science Spain
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- Exploratory Objective To explore changes in muscle mass using nutritional ultrasound.
- 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).
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive of study population
Time frame: Baseline visit (V1)
Descriptive information of the population at V1
14 secondary outcomes
Percentage change of blood test parameters
Time frame: From enrollment to end of treatment at 24 weeks
Percentage of patients with improvement in the nutritional status
Time frame: From enrollment to end of treatment at 24 weeks
Associated cost at 6-month follow-up
Time frame: From enrollment to end of treatment at 24 weeks
Adherence with prescribed oral nutritional supplement (ONS)
Time frame: From enrollment to end of treatment at 24 weeks
Change in functional status of participants over time
Time frame: From enrollment to end of treatment at 24 weeks
Change in NutriQoL® quality-of-life score
Time frame: From enrollment to end of treatment at 24 weeks
Patient satisfaction of the ONS product at 6 months
Time frame: From enrollment to end of treatment at 24 weeks
Patient palatability of the ONS product at 6 months
Time frame: From enrollment to end of treatment at 24 weeks
Health resource use
Time frame: From enrollment to end of treatment at 24 weeks
Change in nutritional status
Time frame: From enrollment to end of treatment at 24 weeks
Percentage change in BMI
Time frame: From enrollment to end of treatment at 24 weeks
Maximum prehensile strenght value
Time frame: From enrollment to end of treatment at 24 weeks
30" chair test
Time frame: From enrollment to end of treatment at 24 weeks
Impedancimetry values
Time frame: From enrollment to end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Malnutrition, run by Outcomes'10 at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mercedes Blanco Naveira, Medical Adviser. MD (+34 628 237 634, mercedes.blanco@es.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive of study population (time frame: Baseline visit (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.