Impact of the Use of Resource® Diabet Plus on Metabolic Control in Patients With T2DM Who Are Malnourished or at Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Glycaemic control
研究概览
简要总结
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.
详细描述
Disease-related malnutrition (DRM) is a nutritional imbalance caused by a nutrient deficiency resulting from one or more underlying pathologies. It 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 around 20-50% of hospitalized patients suffer from DRM, both in acute and chronic conditions. One of the chronic diseases where malnutrition is associated with higher mortality and increased hospital admissions is Type 2 Diabetes Mellitus (T2DM), particularly in the elderly. T2DM is currently one of the most prevalent chronic diseases worldwide, affecting about 10% of the adult population in 2021. Approximately 90% of diagnosed cases of diabetes are type 2, which is not autoimmune-mediated, unlike type 1 (T1DM). T2DM typically develops over time due to factors such as obesity, sedentary lifestyle, high-calorie diets, and aging. Additionally, malnutrition risk is increased in patients with T2DM, which leads to a poorer prognosis.
For the treatment of DRM in diabetic patients, as in other chronic conditions, clinical guidelines recommend a personalized nutritional plan tailored to the patient's needs and characteristics, primarily focused on increasing dietary calorie intake. If this is insufficient, oral nutritional supplements may be necessary. From a clinical perspective, oral nutritional supplements address malnutrition while offering clinical and functional benefits. In diabetic and malnourished patients, it is crucial to maintain good metabolic and glycemic control, which requires diabetes-specific formulas (DSFs).
Unlike standard formulas, which are typically high in carbohydrates, low in lipids, and lack dietary fiber, DSFs contain carbohydrates with low glycemic indices and also include fiber. The purpose of these formulas is to improve the nutritional status of patients without negatively affecting their glycemic profile, aiming for adequate glycated hemoglobin (HbA1c) levels - values under 7% are generally recommended for this population.
Prospective observational studies in malnourished T2DM patients have shown that supplementation with a DSF for at least 12 weeks improves patients' functional and nutritional status, enhances biochemical markers, and does not increase postprandial glucose levels. Additionally, the use of these formulas benefits glycemic and metabolic control in the short and medium term, potentially improving diabetes management and its associated comorbidities, while reducing long-term complications and mortality.
A retrospective study conducted in 2015 in the Spanish diabetic population suggested that this type of DSF may reduce HbA1c in the medium term, facilitating glycemic control and reducing the negative effects of glycemic fluctuations. This could result in a reduced need for insulin as an antidiabetic treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Glycaemic control
时间窗: In 12 and 24 weeks from baseline visit
Changes in HbA1c, meaning a percentage less than 7, good glycaemic control.
次要结局
- Metabolic control(In 12 and 24 weeks from baseline visit)
- Nutritional and functional status(In 12 and 24 weeks from baseline visit)
- Gastrointestinal tolerance(In 12 and 24 weeks from baseline visit)
- Healthcare resource use and associated costs(During 24 weeks from baseline visit)
