TCTR20131206002已完成4 期
Effect of Gen-Premium as a meal replacement on glycemic control in Type 2 diabetes patients: A randomized controlled trial
Thai Otsuka Pharmaceutical Co., Ltd0 个研究点目标入组 120 人开始时间: 2013年12月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.Diagnosed with type 2 DM at least 6 months
- •2.Age of 18 years and older
- •3.Subjects with HbA1C 7-9%
- •4.Subjects with weight changed less than 5% at least 3 months before enrollment
- •5.Subjects with dyslipidemia, continue stable dose of lipid lowering agent at least 3 months before enrollment
- •6.Subjects with diet control, insulin, hypoglycaemic agent at least 6 months with unchanged dose at least 3 months before enrollment
- •7.Willing to participate in the study and sign the inform consent form
排除标准
- •1.Subject with history of severe hypoglycemia with neuroglycopenia
- •2.Subject with severe complication; amputation, diabetic coma
- •3.Subject with history of GI dysfunction such as short bowel syndrome, colectomy
- •4.Subject with cardiovascular diseases; ischemic heart disease, stroke or history of heart failure within 6 weeks before enrollment
- •5.Subject with significant abnormal laboratory value such as hemoglobin < 10 g/dL, WBC < 3000 x 103/ïL, platelet < 100,000 x 103/ïL, AST or ALT > 3 times upper limit of normal, total bilirubin > 2 times upper limit of normal
- •6.Subject with GFR < 60 mL/min/1.73m2
- •7.Subject with psychiatric disorder, alcoholism, drug addiction
- •8.Subject with active thyroid dysfunction
- •9.Subject with malignancy within 5 years before enrollment
- •10.Pregnancy or lactation or refuse effective birth control method
- •11.Subject with herbal, supplements or steroids (except topical steroid) at least 7 days consecutively; or on other investigational drugs within 4 weeks before enrolment
- •12.Subject who is allergic to whey protein isolate (WPI), soy protein isolate, fish oil (except diarrhea from lactose intolerance)
研究者
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