JPRN-jRCT2032230459
尚未招募
3 期
A Randomized Controlled Trial to evaluate effectiveness and safety of potential SaMD in patients with complex Metabolic Syndrome-related diseases.
Svensson Kishi Akiko0 个研究点目标入组 900 人2023年11月19日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Metabolic syndrome with Dyslipidemia, Diabetes Mellitus, Hypertension and Obesity
- 发起方
- Svensson Kishi Akiko
- 入组人数
- 900
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patients who meet the diagnostic criteria for metabolic syndrome.
- •Diagnostic criteria for metabolic syndrome:
- •(1\) Required items: Abdominal circumference of 85 cm or more (men), or 90 cm or more (women).
- •(2\) Patients who meet two or more of the following criteria:
- •1\. Systolic blood pressure of 130 mmHg or higher, or diastolic blood pressure of 85 mmHg or higher.
- •2\. Triglyceride level of 150 mg/dL or more, or HDL cholesterol level less than 40 mg/dL.
- •3\. Fasting blood glucose level of 110 mg/dL or higher.
- •Patients who are being treated with medications for hypertension, dyslipidemia (hypertriglyceridemia or low HDL cholesterolemia), or diabetes mellitus are considered to meet each criterion.
- •2\. Patients who meet two or more of the following criteria related to the definite diagnosis of each disease and the examination result on Visit 1:
- •(1\) Diagnosed with essential hypertension and examination result on Visit 1: Systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher (clinic blood pressure).
排除标准
- •1\. Patients who are recommended for immediate additional drug therapy based on their cerebrovascular and cardiovascular diseases (including their medical history and comorbidity) in guidelines for the management of hypertension, diabetes mellitus, arteriosclerotic disease, dyslipidemia, or obesity, etc.
- •2\. Patients who are taking new medications, changed their prescription, or taking prohibited concomitant medications for diabetes mellitus, dyslipidemia, hypertension, or obesity within the past 24 weeks from the time of obtaining consent.
- •3\. Patients who have intractable diseases that require taking two or more medications for each disease, such as diabetes mellitus, dyslipidemia, hypertension, or obesity (a combination drug with two or more active ingredients is considered as the number of active ingredients).
- •4\. Patients who have been continuously taking OTC and Kampo medicines with weight loss effects for 4 weeks or more within the past 24 weeks from the time of obtaining consent.
- •5\. Patients who have been continuously taking supplements, etc. that are judged by the investigator to affirm body fat reduction, visceral fat reduction, or BMI improvement efficacy for 4 weeks or more within the past 24 weeks from the time of obtaining consent.
- •6\. Patients who have received a weight loss program (including specific health guidance), etc. within the past 24 weeks from the time of obtaining consent.
- •7\. Patients who use a management application with feedback function related to metabolic syndrome and hope to continue using it after participating in this study.
- •8\. Patients who use an activity amount measuring device with feedback function (e.g. wearable device like Fitbit) and hope to continue using it after participating in this study.
- •9\. Patients who have been taking sulfonylurea or using insulin preparations for type 1 diabetes or severe insulin hyposecretion.
- •10\. Patients who have been diagnosed with or strongly suspected of having secondary diabetes.
结局指标
主要结局
未指定
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