NCT01940302已完成早期 1 期
Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes
Shaoguan University1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Metabolic Control
研究概览
简要总结
Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:
- •(1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;
- •Subject is between 18 and 75 years of age, inclusive.
- •Subject's BMI is >18.5 kg/m2 and <35 kg/m
- •If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
排除标准
- •Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type
- •Subject that use exogenous insulin for glucose control.
- •Subject that has a history of diabetic ketoacidosis.
- •Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
- •Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
- •Subject that has had operation less than six months prior to screening visit.
- •Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
- •Subject is known to be allergic or intolerant to any ingredient found in the study product.
结局指标
主要结局
Metabolic Control
时间窗: Twelve weeks
Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention
次要结局
未报告次要终点
研究者
研究点 (1)
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