NCT04168541已完成不适用
Plasma Glucose and Insulin Response to Six 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 14 人开始时间: 2018年2月5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
- 14
- 试验地点
- 2
- 主要终点
- Area under the blood glucose curve (ACU 0-240 minutes)
研究概览
简要总结
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
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)
盲法说明
Study staff will not be blinded to product assignment. Study participants will be blinded to product assignment. Product will be provided in unlabeled plastic cups.
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
- •Subject inclusion criteria
- •All subjects must comply with all the following inclusion criteria:
- •Age 20-75 years
- •Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
- •Hemoglobin A1C less than 9.0%
- •Fasting blood glucose less than 180 mg
- •Hematocrit levels within normal limits
- •Having obtained his/her informed consent
排除标准
- •Subjects representing one or more of the following criteria are excluded from participation in the study.
- •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
- •Patient 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
- •Patients with anemia
结局指标
主要结局
Area under the blood glucose curve (ACU 0-240 minutes)
时间窗: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
次要结局
- Insulinogenic index [Change in Ins30/Change in Glu30]([Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes])
- Area under the insulin curves (AUC 0-240)(Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)
研究者
研究点 (2)
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