KCT0008904招募中Unknown
An observation study on the changes in blood glucose after consumption of oral nutritional supplements for patients with diabetes mellitus
Daesang Wellife0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. Adult aged 19 to 65
- •2. Individuals diagnosed with prediabetes or defined as follows:
- •I. HbA1c: equal to or greater than 5.7% and less than 6.5%, or
- •II. Fasting plasma glucose: equal to or greater than 100mg/dL and less than 126mg/dL
- •3. A person who voluntarily agrees to participate in the study and signs an informed consent form
排除标准
- •1. A person who is diagnosed with type 1 diabetes
- •2. A person who is diagnosed with type 2 diabetes or defined as follows:
- •I. HbA1c: equal to or greater than 6.5% and
- •II. Fasting plasma glucose: equal to or greater than 126mg/dL
- •3. A person with fasting plasma glucose equal to or greater than 180mg/dL
- •4. A person with HbA1c levels equal to or greater than 8.0%
- •5. A person taking oral antidiabetic agents except metformin or undergoing insulin treatment
- •6. A person continuously taken medications or health functional foods that affect blood glucose changes for at least one month prior to enrollment
- •- antidepressants, corticosteroids, antiepileptics, contraceptives, and other drugs affecting blood glucose/appetite/energy metabolism
- •7. A person with a BMI equal to or less than 18.5 kg/m^2 or equal to or greater than 30.0 kg/m^2
- •8. A person with uncontrolled hypertension patients (systolic blood pressure equal to or above 160mmHg or diastolic blood pressure equal to or above 100mmHg)
- •9. A person with AST, ALT, or Cr levels more than twice the normal range
- •10. A person with gastrointestinal disorders that could affect the absorption of the test product or a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery)
- •11. A person with or with a history of cardiovascular, endocrine metabolic, respiratory, hepatobiliary, renal, blood, or tumor disorders requiring treatment
- •12. A person with chronic infections such as tuberculosis, hepatitis B, hepatitis C, HIV, etc
- •13. A person with abnormal thyroid function
- •14. A person practicing specific dietary regimens
- •15. A person allergic or hypersensitive to the components of the test product
- •16. A person with a history of alcohol addiction or suspected alcohol abuse
- •17. A person who participated in another clinical trial one month before participation in the test
- •18. A person who pregnant or lactating
- •19. A person who is illiterate or whose ability is limited
- •20. A person deemed inappropriate by the principal investigator to participate in the research
研究者
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