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临床试验/KCT0000315
KCT0000315尚未招募未知

Weight-control Effect of Rice-based Diet

Inje University Seoul Paik Hospital0 个研究点目标入组 800 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
800

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 60(Year)(—)
性别
All

入选标准

  • ? any 3 of 5 constitute diagnosis of metabolic syndrome
  • 1. Elevated waist circumference : =90 cm in men
  • =85 cm in women
  • 2. Elevated triglycerides : =150 mg/dL (1.7 mmol/L)
  • or On drug treatment for elevated triglycerides
  • 3. Reduced HDL-C : <40 mg/dL (1.03 mmol/L) in men
  • <50 mg/dL (1.3 mmol/L) in women
  • or On drug treatment for reduced HDL-C‡
  • 4. Elevated blood pressure: =130 mm Hg systolic blood pressure or
  • =85 mm Hg diastolic blood pressure or
  • On antihypertensive drug treatment in a patient
  • with a history of hypertension
  • 5. Elevated fasting glucose : =100 mg/dL
  • or On drug treatment for elevated glucose
  • ? Patients who agreed to write about food diary and physical activity Questionnaire
  • ? Patients who agreed to participate volutary in this clinical trial

排除标准

  • ? The patients with physical measurements are difficult due to anatomical change, such as surgical resection of part of the body
  • ? The Patients with thyroid fuction disease (TSH is under 0.1 uU/ml, or over 10 uU/ml)
  • ? The Patients with severe cerebrovascular disease(infarct, hemorrage), cardiac disease(angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator)
  • ? The Patients with severe liver or kidney function abnormality
  • - plasma ALT or AST level is more than 3 times the upper limit of normal
  • - plsma creatinine level is more than 1.5 times the upper limit of normal
  • ? The Patients with mental illness such as depression, Schizophrenia, alcoholism, drug addiction etc.
  • ? Pregnant and lactating women, and women of childbearing age who do not agree with choose an appropriate contraceptive method or are planning to pregnant
  • ? The patient who take the medicine that can affect the state of weight, glucose and lipid level (uptake inhibitors, antidepressant, appetite suppressant, antiobesity-related health functional food / supplements, antipsychotics, contraceptives, steroid, and hormon)within recent 3 months
  • ? The patients who had surgical procedure for reducing weight (bariatric surgery such as gastric bypass and gastric banding)
  • ? The patients who lose weignt over 10 percent within 3 months
  • ? The patients who took part in other clinical trial within 3 months
  • ? The patients who cannot excersise due to severe musculoskeletal disorders
  • ? The patients who stopped smoking within recent 6 months or chage frequently smoking habit
  • ? The patients who have low motivation for attending or will not following the observances of this clinical trial, depend on opinion of representative clinical trials

研究者

发起方
Inje University Seoul Paik Hospital

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Weight-control Effect of Rice-based Diet | 临床试验