NCT04313920已完成不适用
Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 6
- 主要终点
- Plasma Glucose Concentration
研究概览
简要总结
The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Subject is healthy or has pre-diabetes or type 2 diabetes
- •Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
- •Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2
- •If subject is on a chronic medication, the dosage has been constant
- •Subject states willingness to follow protocol
排除标准
- •Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
- •Subject has type 1 diabetes
- •Subject has a history of diabetic ketoacidosis
- •Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
- •Subject has an active malignancy
- •Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
- •Subject has end-stage organ failure or is status post organ transplant.
- •Subject has a history of renal disease
- •Subject has current hepatic disease
- •Subject has a history of severe gastroparesis
- •Subject has a chronic, contagious, infectious disease
- •Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
- •Subject has clotting or bleeding disorders
- •Subject is known to be allergic or intolerant to any ingredient found in the study products
- •Subject is a participant in another study that has not been approved as a concomitant study
结局指标
主要结局
Plasma Glucose Concentration
时间窗: Baseline 0 to 240 Minutes
Area under the curve
次要结局
- Gastric Emptying(Baseline 0 to 180 Minutes)
- Nutritional Product Assessment(Immediately following product consumption)
- Serum Insulin Concentration(Baseline 0 to 240 Minutes)
- Subjective Appetitive Ratings(Baseline 0 to 240 Minutes)
研究者
研究点 (6)
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