NCT02446054已完成不适用
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
Celio Technology Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the change of glycosylated hemoglobin (HbA1c)
研究概览
简要总结
Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control
详细描述
In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
- •The subject is able to understand and comply with protocol requirements, instrument
- •The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
- •Signed and dated written informed consent
排除标准
- •Pregnancy, breastfeeding or planning to become pregnant during the study
- •Acute illness or infection requiring treatment within 14 days of study entry
- •Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
- •Presence of malignancies
- •Participate in other clinical trial within 30 days prior to this study
- •Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator)
- •Concurrent significant medical condition that would limit ability to participate in the study
- •Consider by the investigator to be unsuitable for study participation, for any reason
研究组 & 干预措施
One Arm Study
Experimental
provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
干预措施: Musashino T2DM diet (Dietary Supplement)
结局指标
主要结局
the change of glycosylated hemoglobin (HbA1c)
时间窗: 12 weeks
12 weeks diet control
次要结局
- the change of patients' fasting blood Glucose(12 weeks)
- the change of patients' fasting serum C-peptide(12 weeks)
- the change of EuroQol EQ-5D questionnaire(12 weeks)
- the change of patients' fasting serum Insulin(12 weeks)
- the change of WHO-QoL questionnaire(12 weeks)
- the patients' compliance questionnaire(12 weeks)
研究者
研究点 (1)
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