Clinical trial NCT06866366: Retrospective, Multicenter, Single-arm, Observational Study, With Data From Patients With T2DM With Malnutrition or at Risk, Who Were Prescribed Resource® Diabet Plus as a Hypercaloric and Hyperproteic Specific Formula for Patients With T2DM
Official title: Impact of the Use of Resource® Diabet Plus on Metabolic Control in Patients With T2DM Who Are Malnourished or at Risk of Malnutrition
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malnourished Elderly
Malnourishment
Diabetes Mellitus Type 2
Keywords: DRM
Disease - realted malnutrition
Diabetes-specific formula
Metabolic control
Oral nutritional supplementation
DSF
T2D
Lead sponsor: Outcomes'10
Sponsor class: NETWORK
Collaborators: name: Nestlé Health Science Spain
First posted: 2025-03-10
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patient with malnutrition or at risk of malnutrition, treated for it in hospitals of the national network who have been prescribed 1-2 bottles/day of Resource® Diabet Plus

Brief summary: This retrospective multicentre study aims to provide real-world evidence of the effectiveness of Resource® Diabet Plus as supplementation tool for T2DM patients with malnutrition or at risk of malnutrition, under conditions of routine clinical practice in Spain.

Detailed description: Disease-related malnutrition (DRM) is a nutritional imbalance generated due to a nutrient deficit caused by one or more previous pathologies and is the main cause of malnutrition in developed countries, with a prevalence of around 30 million people in Europe in 2020. In Spain, it is estimated that, in the hospital setting, around 20-50% of patients suffer from DRM, both in acute and chronic pathologies. One of the chronic diseases where malnutrition is associated with a higher risk of mortality and a higher prevalence of hospital admissions is Type 2 Diabetes (T2DM), especially in the elderly. T2DM is currently one of the most prevalent chronic diseases worldwide, affecting about 10% of the adult population in 2021. About 90% of diagnosed cases of diabetes are of type 2, also called non-immune-mediated to differentiate it from type 1 (T1DM). T2DM is acquired over the years due to different factors, such as obesity, sedentary lifestyle, high-calorie diets and ageing, among others. In addition, the risk of malnutrition is increased in T2DM, which confers a worse prognosis.

For the treatment of DRM in diabetic patients, as in other chronic pathologies, clinical guidelines recommend following a personalised nutritional plan adapted to the patient's needs and characteristics, based on increasing dietary calorie intake, and if this is not sufficient, it may be necessary to treat the patient with oral nutritional supplements. From a clinical point of view, oral nutritional supplements are a solution to address malnutrition, contributing to clinical and functional benefits. In the context of the diabetic and malnourished patient, it is also essential to maintain good metabolic and glycaemic control, requiring diabetis-specific formulas (DSF).

Unlike standard formulas that are high in carbohydrates, low in lipids and do not contain dietary fibre, DSF contain carbohydrates with low glycaemic indices and also add fiber to their formula. The aim of these formulas is to improve the nutritional status of these patients without altering the glycaemic profile and to achieve adequate levels of glycated haemoglobin (HbA1c), with HbA1c values of \<7% being recommended in this population.

Prospective observational studies conducted in malnourished patients with T2DM have shown that supplementation with an DSF for a period of at least 12 weeks improves the functional and nutritional status of patients, improving analytical biochemical parameters, without increasing postprandial glucose levels. In addition, the use of these formulas benefits diabetic patients, favouring their glycaemic and metabolic control in the short/medium term, which would mean an improvement in the management of diabetes and its associated comorbidities, reducing the risk of complications and mortality in the long term.

A retrospective study conducted in 2015 in the Spanish diabetic population suggested that this type of DSFs could have an impact on the reduction of HbA1c in diabetic patients in the medium term, facilitating glycaemic control and reducing the negative effects of glycaemic fluctuations, which could be translated into a lower requirement for insulin as an anti-diabetic treatment.

The aforementioned evidence points to the benefits of the use of DSF in diabetic patients, helping them to maintain metabolic control, facilitating nutritional, functional and clinical improvement, which also means fewer hospital visits and hospitalisations, but more studies are needed in this field to support the advantages of using these nutritional formulas specifically designed for diabetic and malnourished patients, which, despite being somewhat more expensive than standard supplementation formulas, help the patient to achieve better metabolic control, thus contributing to lower healthcare costs.

Not many retrospective studies have been conducted in the field of nutrition in the diabetic and malnourished patient, with most of the data available coming from prospective studies or literature reviews. However, the characteristics of retrospective, real-life studies allow the effects of exposure to an DSF in a given population to be assessed over a relatively short period of time, reflecting the management of the malnourished diabetic patient in the context of clinical practice.

This retrospective study aims to provide real-life evidence of the effectiveness of Resource® Diabet Plus supplementation as an DSF in diabetic patients with malnutrition or at risk, under conditions of routine clinical practice in Spain.

OBJECTIVES OF THE STUDY Primary objective

- To assess the effects of Resource® Diabet Plus on glycaemic control in patients with T2D who are malnourished or at risk, 12 and 24 weeks after initiation of nutritional therapy.

Secondary objectives:

* To assess the effects of Resource® Diabet Plus on the metabolic control of the malnourished or at-risk T2D patient 12 and 24 weeks after initiation of Resource® Diabet Plus treatment.
* To describe the evolution of the nutritional and functional status of patients with T2D who are malnourished or at risk 12 and 24 weeks after starting Resource® Diabet Plus.
* To describe the presence of gastrointestinal symptoms in patients treated with Resource® Diabet Plus.
* To analyse the use of healthcare resources and associated costs after 24 weeks of treatment with Resource® Diabet Plus.

METHODOLOGY Study design and scope Retrospective, multicentre, single-arm, observational study with data from patients at risk of malnutrition detected by validated screening tools or with DRM diagnosed by GLIM criteria, who were prescribed a specific hypercaloric and hyperprotein formula for diabetic patients: Resource® Diabet Plus. The study will be conducted in the Endocrinology and Nutrition Departments of four Spanish hospitals.

The prescription of Resource® Diabet Plus should be between two years and 24 weeks before the start of the study. Clinical history data will be collected at the time of prescription of Resource® Diabet Plus, this will be the index date (V0) and subsequently patient evolution data will be collected at 12 (V1) and 24 weeks (V2) with a two-week window to adjust to the practice of each centre. The investigators will have a 3-month period for patient identification and data collection

Identification and description of the study product The study product is Resource® Diabet Plus, a hyperprotein and hypercaloric (1.6kcal/mL) oral nutritional formula with fibre, formulated from milk protein and 100% soluble fibre, which makes it a suitable dietary treatment for patients with type 1 diabetes, T2D or hyperglycaemia with increased energy and protein needs and pathologies involving nutritional risk or malnutrition.

Resource® Diabet Plus comes in 200mL bottles, each containing: 18g of protein, 5g of soluble fibre and 7.2g of monounsaturated fatty acids from vegetable oils. Product Nutritional Information (Resource® Diabet Plus).

In addition, Resource® Diabet Plus contains slowly absorbed glycaemic index carbohydrates (GI\<55), making it a suitable product for achieving metabolic targets while maintaining glycaemic control.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years.
* Outpatients or hospitalised patients, at discharge with a diagnosis of type 2 Diabetes.
* Patients at risk of malnutrition detected by validated screening tools or with DRM diagnosed by GLIM criteria.
* Patients who have been prescribed 1-2 bottles/day of Resource® Diabet Plus following the conditions of use of its technical data sheet, in the last 2 years, with at least 24 weeks of evolution recorded in the clinical history.
* Patients who have Hb1Ac data in the medical record on the index date and during evolution.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients who required any other type of nutritional supplementation during the study period (parenteral/enteral).
* Patients with severe renal insufficiency (glomerular filtration rate \< 30mL/min/1.73m2) at the time of selection.

Primary outcomes:
measure: Glycaemic control
timeFrame: In 12 and 24 weeks from baseline visit
Secondary outcomes:
measure: Metabolic control
timeFrame: In 12 and 24 weeks from baseline visit
measure: Nutritional and functional status
timeFrame: In 12 and 24 weeks from baseline visit
measure: Gastrointestinal tolerance
timeFrame: In 12 and 24 weeks from baseline visit
measure: Healthcare resource use and associated costs
timeFrame: During 24 weeks from baseline visit
Other outcomes:
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Study officials:
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