NCT02881164已完成不适用
Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Glycemia
研究概览
简要总结
To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 47 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes mellitus diagnosis.
- •Minimum period of six months under intensive insulin therapy.
- •Fast insulin prescription before breakfast.
- •35 and 70 years of age.
- •BMI between 25 and 39.9 Kg/m
- •HbA1c less than or equal to 10 % (86mmol/mol)
- •Menopausal women under hormone replacement therapy
排除标准
- •Pregnant women.
- •Puerperal women.
- •Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
- •Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.
研究组 & 干预措施
Low glycemic index breakfast
Experimental
Low glycemic index breakfast (GI=45)
干预措施: Low glycemic index (Other)
High glycemic index breakfast
Active Comparator
High glycemic index breakfast (GI=80)
干预措施: High glycemic index (Other)
结局指标
主要结局
Glycemia
时间窗: -15 up to 120 minutes
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
Satiety
时间窗: Up to 120 minutes
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
次要结局
未报告次要终点
研究者
Claudia Vega Soto
Nutritionist
Universidad de Valparaiso
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