Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial
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 preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum period of six month intensive insulin therapy
- •Prescription rapid insulin in the breakfast
- •Aged 35 to 70 years
- •BMI 25 to 39.9 kg / m2
- •HbA1c lower than or equal to 10% (86 mmol / mol)
- •Menopausal women under hormone replacement therapy
排除标准
- •History of intolerance artificial sweetener sucralose
- •Pregnant women
- •Puerperal women
- •Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV
- •Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection
研究组 & 干预措施
Water
200 mL of water
干预措施: Placebo (Other)
Sucralose
14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water
干预措施: Sucralose (Other)
结局指标
主要结局
Glycemia
时间窗: 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).
C peptide
时间窗: up to 60 minutes
C-peptide at -15 and 60 minutes with respect to breakfast intake
次要结局
未报告次要终点
研究者
Claudia Vega Soto
Nutritionist
Universidad de Valparaiso