JPRN-jRCTs032210304已完成2 期
A Prospective Open-label Randomized Controlled Trial of Continuous Lifestyle Intervention with a Designated Treatment Application for Metabolic syndrome Patients with Dyslipidemia, Diabetes Mellitus, Hypertension and Obesity
agashima Hirotaka0 个研究点目标入组 100 人开始时间: 2021年9月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Those who have metabolic syndrome and who
- •satisfy two or more of (1)to (4)
- •Diagnostic criteria for metabolic syndrome
- •Required items: Abdominal circumference 85 cm (men) or 90 cm (women) or more.
- •And one or more of the following items apply.
- •1.Triglyceride 150 mg / dl or more or HDL cholest
- •erol less than 40 mg / dl
- •2.Systolic blood pressure 130 mmHg or higher or
- •diastolic blood pressure 85 mmHg or higher
- •3. Fasting blood glucose 110 mg / dl or higher
- •(1)Degree I or degree II essential hypertension
- •(2)Type 2 diabetes
- •(3)Dyslipidemia
- •(4)BMI 30g / m2 or more due to obesity
- •2) Men and women aged 20 to 75 at the time of c
- •3) Those who have received sufficient explanation
- •for participating in this study, and who have obtained sufficient understanding and consent to the document at their own free will.
- •4) Those who are comfortable wearing wearable devices except when taking a bath or charging
- •5) Those who have experience of using smartphon
- •es for 3 months or more
- •6) Those who have a scale at home (with or without fat measurement)
排除标准
- •1) Those who are recommended for immediate drug therapy based on their medical history, comorbidity, and risk of cerebrocardiovascular disease in the guidelines, etc.
- •2) Those who are taking new medications for diabetes, dyslipidemia, hypertension, obesity, or whose prescription amount has been changed in the past 6 months from the time of obtaining conset.
- •3) Those who have received weight loss programs
- •(including specific health guidance) in the past 6 months from the time of obtaining consent
- •4) Those who have been diagnosed with or strongly suspected of having type 1 diabetes or secondary diabetes
- •5) Those who have been diagnosed or strongly suspected of having secondary hypertension
- •6) Those who have been diagnosed with endocrine diseases such as hyperthyroidism, hypothyroidism, Cushing's syndrome, and hyperaldosteronism.
- •7) Persons with moderate or severe heart disease (requiring outpatient treatment) or a history
- •8) Persons with HbA1c 9% or more within 3 months at the time of obtaining consent or the latest test results
- •9) Persons with essential hypertension with grade 3 hypertension (examination room systolic blood pressure 180 mmHg or higher and / or diastolic blood pressure 110 mmHg or higher) within 3months at the time of consent acquisition or the latest test results
- •10) Those who have eGFR less than 45 mL / min /1.73 m2 or urinary Alb / Cre 300 mg / g Cre within 3 months at the time of obtaining consent or the latest test result
- •11) Those who have been pointed out to have retinopathy severe than pre proliferative retinopathy.
- •12) Those who are taking drugs that affect glucose tolerance and lipid metabolism (steroid drugs, etc.).
- •13) Those who have been instructed by a doctor that they cannot perform exercise therapy.
- •14) Pregnant or lactating women and women with the potential (will) to become pregnant.
- •15) Persons with sensitive skin (metal allergies, etc.) who have difficulty using wearable devices for a long time.
- •16) Those who have night shifts and weekend shifts.
- •17) Others who are judged by the investigator (sharing) to be inappropriate for this study.
研究者
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