Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07252765
NCT07252765RecruitingNot Applicable

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

Outcomes'1012 sites in 1 country334 target enrollmentStarted: November 20, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
334
Locations
12
Primary Endpoint
Descriptive of study population
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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

Outcomes

Primary Outcomes

Descriptive of study population

Time Frame: Baseline visit (V1)

Descriptive information of the population at V1

Secondary Outcomes

  • Adherence with prescribed oral nutritional supplement (ONS)(From enrollment to end of treatment at 24 weeks)
  • Percentage of patients with improvement in the nutritional status(From enrollment to end of treatment at 24 weeks)
  • Associated cost at 6-month follow-up(From enrollment to end of treatment at 24 weeks)
  • Percentage change of blood test parameters(From enrollment to end of treatment at 24 weeks)
  • Change in functional status of participants over time(From enrollment to end of treatment at 24 weeks)
  • Maximum prehensile strenght value(From enrollment to end of treatment at 24 weeks)
  • Change in NutriQoL® quality-of-life score(From enrollment to end of treatment at 24 weeks)
  • Patient satisfaction of the ONS product at 6 months(From enrollment to end of treatment at 24 weeks)
  • 30" chair test(From enrollment to end of treatment at 24 weeks)
  • Patient palatability of the ONS product at 6 months(From enrollment to end of treatment at 24 weeks)
  • Health resource use(From enrollment to end of treatment at 24 weeks)
  • Change in nutritional status(From enrollment to end of treatment at 24 weeks)
  • Percentage change in BMI(From enrollment to end of treatment at 24 weeks)
  • Impedancimetry values(From enrollment to end of treatment at 24 weeks)

Investigators

Sponsor
Outcomes'10
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (12)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Representation of Diet in the Management of Type 2 Diabetes in Migrant Patients at CHSDDiabetes Mellitus, Type 2
NCT06969391Centre Hospitalier de Saint-Denis11
Not yet recruiting
Phase 4
Nutritional Assessment & Intervention through Dietary Counselling with Lifestyle Modification in Vitamin B12 deficient Diabetic Patients its Correlation with Peripheral Neuropathy.Type 2 diabetes mellitus with unspecified complications,
CTRI/2023/07/055208Jahnvi Sharma252
Completed
Not Applicable
Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)Diabetes Mellitus, Type 2
NCT03793855Hospital do Coracao370
Not yet recruiting
Not Applicable
Study of dietary fiber to improve blood sugar levels in patients having Type II DiabetesType II Diabetes Mellitus
CTRI/2015/07/006015Mr Ajay Nilawar30
Completed
Not Applicable
Nutritional Assessment in Mitochondrial CytopathyMitochondrial DiseasesMitochondrial MyopathiesMitochondrial Cytopathies
NCT02375438Insel Gruppe AG, University Hospital Bern26