Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nestlé Health Science Spain | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive of study population | Descriptive information of the population at V1 | Baseline visit (V1) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status at molecular level | Test: nutritional (morphofunctional) ecography | From enrollment to end of treatment at 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mercedes Blanco Naveira, Medical Adviser. MD | Contact | +34 628 237 634 | mercedes.blanco@es.nestle.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Hospital Universitario Juan Ramón Jiménez |
| Recruiting |
| Huelva |
| Huelva |
| 21005 |
| Spain |
| Hospital UniversitarioDoctor Negrín | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
| Hospital Clínico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
| Hospital Virgen de la Victoria | Recruiting | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Sevilla | 41005 | Spain |
| Hospital Universitario Virgen de la Macarena | Recruiting | Seville | Sevilla | 41009 | Spain |
| Hospital La Fe | Recruiting | Valencia | Valencia | 460026 | Spain |
| Hospital General de Valencia | Recruiting | Valencia | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009748 | Nutrition Disorders |
Not provided
Not provided