NCT05423938已完成不适用
Efficacy of Two Formulas of Oral Nutritional Supplementation on Metabolic Parameters and Glycemic Monitoring in Patients at Nutritional Risk With Type 2 Diabetes Mellitus
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Postprandial glycemic response
研究概览
简要总结
Rationale: The aim of the study was to compare the glycemic and insulinemic response of malnourished patients with type 2 diabetes after oral feed between a diabetic oral nutritional supplements (ONS) and a standard one.
Methods: Randomized, double-blind, crossover, multicenter clinical trial, conducted in patients with type 2 diabetes and a diagnosis of malnutrition (SGA). Patients were randomized to receive two ONS: diabetic (Bi1 diacare hp/hc) or control (standard, isocaloric and isoproteic), a week apart. A glycemia and insulinemia curve was made at times: 0', 30', 60', 90', 120', and 180', after drank 200 ml of the ONS. The analyzed variables were the area under the curve (AUC 0-t) of glucosa and insulin, and the maximum concentration of glucose (Cmax).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Diagnosed with DM2 (confirmed by the use of oral hypoglycemic agents for at least two months).
- •Patients at nutritional risk diagnosed through the Subjective Global Assessment.
- •Adequate cultural level and understanding of the clinical study.
- •Agree to voluntarily participate in the study and give their informed consent in writing.
- •Non-pregnant and non-lactating women or women who have given birth at least six weeks prior to the screening visit.
排除标准
- •Type 1 DM, DM2 with insulin treatment and DM secondary to steroids.
- •Consumption of alpha-glucosidase inhibitors.
- •Current infection (requiring medication or hospitalization), patients undergoing inpatient surgery, or receiving corticosteroids within the past three months or antibiotics within the past three weeks prior to Screening Visit.
- •BMI > 35 Kg/m
- •Active malignant neoplasm (except the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the cervix uteri).
- •End-stage organ failure (such as end-stage renal disease) or organ transplant.
- •Advanced chronic kidney disease (glomerular filtration rate < 30 ml/min).
- •Severe liver disease.
- •Severe gastroparesis.
- •Chronic infectious disease, such as active tuberculosis, hepatitis B or C, or HIV infection.
- •Consumption of phytotherapy products, dietary supplements or medications except oral hypoglycemic agents, during the four weeks prior to the screening visit, which could profoundly affect (in the opinion of the PI) blood glucose.
- •Allergy or intolerance to any component of the products under study.
- •Participation in a concurrent trial that conflicts with this study.
结局指标
主要结局
Postprandial glycemic response
时间窗: 180 minutes
次要结局
- Postprandial insulin response(180 minutes)
研究者
研究点 (1)
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