NCT02856516已完成不适用
Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年7月1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
- 12
- 试验地点
- 2
- 主要终点
- Area under the blood glucose curve (AUC 0-240)
研究概览
简要总结
This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.
详细描述
Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-75 yrs
- •Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- •Hemoglobin A1C less than 9.0%
- •Fasting blood glucose less than 180 mg
排除标准
- •Abnormal thyroid function
- •Creatinine >2.0 mg/dL
- •Potassium <3.5 mEq/L
- •Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- •Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
- •Unable to give informed consent or follow instructions
- •Current insulin therapy or insulin therapy within the past month
- •Patients who are pregnant
- •Allergies to milk, soy or any component of the test product
- •Patient who in the Investigators assessment cannot be expected to comply with treatment
- •Currently participating or having participated in another clinical trial.
结局指标
主要结局
Area under the blood glucose curve (AUC 0-240)
时间窗: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
次要结局
- Area under the insulin curves (AUC 0-240)(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
- AUC (0-30min) for insulin(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
- Insulinogenic index (Ins30/(Glu30)(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
研究者
研究点 (2)
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