A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
研究概览
详细说明
The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
-
-
South Dakota
-
Sioux Falls、South Dakota、美国、57105
- Avera Research Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women who are at least 18 years old
- Diagnosis of Type 2 Diabetes
- Has been on stable diabetes medication/insulin for the past three months
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Diagnosis of Celiac Disease or gluten intolerance
- Current or active kidney disease
- Current or active liver disease
- Any food allergies
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Nutralin
Individuals with Type 2 Diabetes
|
7 capsules taken 15 minutes before each of the three main meals of the day
|
|
安慰剂比较：Placebo
Individuals with Type 2 Diabetes
|
7 capsules taken 15 minutes before each of the three main meals of the day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Sugar
大体时间：16 weeks
|
blood sugar levels
|
16 weeks
|
|
HgA1c reduction
大体时间：16 weeks
|
reduction of Hemoglobin A1c levels
|
16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diabetes medication
大体时间：16 weeks
|
reduction in the amount of diabetes medication needed
|
16 weeks
|
合作者和调查者
调查人员
- 首席研究员：Edward Zawada, MD、Avera McKennan Hospital & University Health Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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