NCT03155867已完成不适用
Plasma Glucose and Insulin Response to Six Meal Replacements 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 13 人开始时间: 2017年4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
- 13
- 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 six interventions on six separate study days, 1 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)
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 alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
- •Hemoglobin A1C less than 9.0%
- •Fasting blood glucose less than 180 mg
- •Hematocrit levels within normal limits
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
- •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 (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)
- Insulinogenic index [Change in Ins30/Change in Glu30](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)
研究者
研究点 (2)
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