Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Assessment of the change in HbA1C (%) relative to baseline
研究概览
简要总结
The purpose of this study is to determine whether the freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, also evaluate its ability to postpone prediabetes patients to become diabetes.
详细描述
This study aims to evaluate the effect of freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be collected and put into analysis to provide some suggestions on the Clam protein capsules and Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •Agree to cooperate in the trial and sign the written informed consent
- •Age 25-70 years
- •Glucose AC between 100-125 mg/dL
- •HbA1c between 5.7%~6.4%
- •Total Cholesterol≧160mg/dL or LDL-C≧100mg/dL Remark: Meet one of the (3)~(5) conditions is acceptable
排除标准
- •Pregnant and lactating women
- •Poor medication compliance
- •Abnormal liver function patients (ALT and AST value> 2 folds of normal value upper limit )
- •Abnormal renal function patients (creatinine value>1.5 mg/dL)
- •Abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and diarrhea)
- •Sever comorbidity in the last 6 months. (eg. Brain stroke, myocardial infarction, and major trauma and surgery)
- •Using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones, corticosteroids, H2 blockers, diuretics and Statin )
- •Diabetes patients
- •Other sever diseases ( malignant tumor and alzheimer's disease)
- •With inflammatory diseases, infectious disease, and severe immune deficiency ( eg. tuberculosis, AIDS, active pneumonia, systemic lupus erythematosus and rheumatoid arthritis)
- •Other influence blood sugar endocrine disease (eg. Hyperthyroidism, Acromegaly, Cushing's syndrome and Pheochromocytoma)
结局指标
主要结局
Assessment of the change in HbA1C (%) relative to baseline
时间窗: 6 months
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in lipid profile relative to baseline
时间窗: 6 months
Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
Assessment of the change in inflammation index relative to baseline
时间窗: 6 months
Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
Assessment of the change in liver function relative to baseline
时间窗: 6 months
Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
Assessment of the change in renal function relative to baseline
时间窗: 6 months
Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline
时间窗: 6 months
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline
时间窗: 6 months
Assessment of the change in fasting glucose (mg/dl) relative to baseline
次要结局
未报告次要终点