Study to Evaluate the Effect of Consuming an Oral Nutritional Supplement (ONS) Specifically for Diabetic Patients on Adherence and Gastrointestinal Tolerance and Nutritional Status in Patients With DM2 and Malnutrition
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fat mass (%)
研究概览
简要总结
Diabetes Mellitus (DM) is one of the most prevalent chronic diseases today, it is reaching epidemic proportions, mainly caused by the increase in type 2 diabetes (DM2).The foundation of any hypoglycemic treatment is based on a healthy diet, daily physical exercise and adequate health education with the collaboration of the patient. Diet is sometimes the only necessary therapy since approximately 80% of patients with DM2 are usually overweight, what is mainly wanted with diet is to achieve normal blood glucose levels both fasting and in the postprandial phase. This diet must be a varied diet combining foods from the different food groups; however, carbohydrate control must be one of the key strategies for glycemic control. Currently, there is also talk of the concept of disease-related malnutrition (DRM). DRM is malnutrition associated with a pathological state, with the presence of inflammation being a key factor in determining its etiology. This inflammation can be chronic or acute depending on the type of pathology. Therefore, the fiber and carbohydrate composition of oral nutritional supplements are important for glycemic control, so a study is proposed to evaluate the effect of consuming a ONS hypercaloric/high-protein (HC/HP) with fiber, and enriched in calcium, Vitamin D and DHA on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition.
详细描述
Longitudinal, prospective exploratory study, to evaluate the effect of consuming an oral nutritional supplement (ONS) HC/HP with fiber, and enriched in calcium, Vitamin D and Docosahexaenoic acid (DHA) on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition, in a period of 60 days. Twenty-four volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: men and woman enter 18 and 85, with DM2 previously diagnosed and controlled, with malnutrition diagnosed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, who require taking ONS, willing to consume the ONS during the study and adequate cultural level and understanding of the clinical study. Follow up will include 4 individualized visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women enter 18 and 85 years old.
- •Patients with DM2 previously diagnosed and controlled.
- •Patients with malnutrition diagnosed according to GLIM criteria.
- •Patients who require taking ONS.
- •Patients willing to consume the ONS during the study period.
- •Patients with adequate cultural level and understanding of the clinical study.
- •Patients who agree to voluntarily participate in the study and who give their informed consent in writing.
排除标准
- •Subjects with enteral or parenteral nutrition.
- •Subjects with poorly controlled DM
- •Subjects with dementia, eating behavior disorders, history of serious neurological or psychiatric pathology that may interfere with adherence to the consumption of the ONS.
- •Subjects suffering from alcoholism or substance abuse that may interfere with adherence to the consumption of the ONS.
- •Subjects with a diagnosis of kidney or liver disease under pharmacological treatment.
- •Subjects with infections or any condition that interferes with nutrient digestion, absorption, metabolism, or excretion (including gastroparesis).
- •Subjects with chronic gastrointestinal diseases that affect the digestion or absorption of nutrients.
- •Subjects with allergies or intolerances to any of the ingredients of the formula.
- •Subjects with socio-family problems that prevent them from participating in the study.
- •Pregnant or lactating women.
结局指标
主要结局
Fat mass (%)
时间窗: Day 0, Day 60
Changes in the percentage (%) of Fat Mass via bioelectrical impedance
Weight gain (kg)
时间窗: Day 0, Day 60
Changes in body weight. It is measured using a digital scale for clinical use (capacity 0-150 kg),with the person positioned with their back to the viewer, without shoes, wearing a minimum of warm clothing (pants and t-shirt), heels together, looking forward and posture straight body.
Muscle mass (%)
时间窗: Day 0, Day 60
Changes in the percentage (%) of Muscle Mass via bioelectrical impedance
次要结局
- Urate serum concentration (mg/dL)(Day 0, Day 60)
- Waist circumference (cm)(Day 0, Day 60)
- Intracellular water (%)(Day 0, Day 60)
- Albumin serum concentration (g/dL)(Day 0, Day 60)
- Creatinine serum concentration (mg/dL)(Day 0, Day 60)
- Prealbumin serum concentration (mg/dL)(Day 0, Day 60)
- Insulin serum concentration (IU/mL)(Day 0, Day 60)
- HbA1c serum concentration (%)(Day 0, Day 60)
- Total Body Water (%)(Day 0, Day 60)
- Triglycerides serum concentration (mg/dL)(Day 0, Day 60)
- 24 hour food record questionnaire(Day 0, Day 60)
- Gastrointestinal symptoms rating scale (GSRS)(Day 0, Day 60)
- Extracellular water (%)(Day 0, Day 60)
- Body Cell Mass (%)(Day 0, Day 60)
- Glucose serum concentration (mg/dL)(Day 0, Day 60)
- Questionnaire on quality of life (EuroQoL 5D)(Day 0, Day 60)
- Body Mass Index (kg/m2)(Day 0, Day 60)
- Phase angle (º)(Day 0, Day 60)
- Total Cholesterol serum concentration (mg/dL)(Day 0, Day 60)
- LDL-cholesterol serum concentration (mg/dL)(Day 0, Day 60)
- HDL-cholesterol serum concentration (mg/dL)(Day 0, Day 60)
- Adherence to the Mediterranean Diet(Day 0, Day 60)
- International Physical Activity Questionnaire (IPAQ)(Day 0, Day 60)
- Sensory perception(Day 0, Day 60)