The METABO Trial

JRCT ID: jRCT2032230459

Registered date:19/11/2023

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Metabolic syndrome with Dyslipidemia, Diabetes Mellitus, Hypertension and Obesity
• Date of first enrollment: 24/01/2024
• Target sample size: 900
• Study type: Interventional

Intervention(s)

Intervention group: Participants will continue to use the MED MIRAI intervention for 12 or 24 weeks and receive feedback on lifestyle management and improvement based on each treatment guideline through a smartphone application. During medical consultations, participants will review their daily life status with the doctor through a web application for doctors, receive advice on lifestyle habits, and collaborate with the doctor to create a long-term action plan until the next consultation, using the doctor's web application with automatic suggestions as a reference.
Control Group: Receive guidance on lifestyle management and improvement in accordance with each treatment guideline during medical consultations.

Outcome(s)

Primary Outcome

In the following five main evaluation items 1)~5), the superiority over the control group will be examined.
1. Change in the number of risks from the baseline at 12 weeks after trial registration
Note that the number of risks is defined as the number of cases corresponding to triglycerides >= 150 or HDL < 40, systolic blood pressure >= 130 or diastolic blood pressure >= 85, fasting blood glucose >= 110, and waist circumference >= 85, 90 (for males, females respectively) based on the criteria for metabolic syndrome.
2. Change in triglycerides from the baseline at 12 weeks
3. Change in BMI from the baseline at 12 weeks
4. Change in fasting blood glucose from the baseline at 12 weeks
5. Change in systolic blood pressure from the baseline at 12 weeks

Secondary Outcome

In the following 5 important secondary evaluation items 1)~5),the superiority over the control group will be examined.
1. Change from baseline in the number of risks at 24 weeks after trial registration
2. Change from baseline in triglycerides at 24 weeks
3. Change from baseline in BMI at 24 weeks
4. Change from baseline in fasting blood glucose at 24 weeks
5. Change from baseline in systolic blood pressure at 24 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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).
(2) Diagnosed with type 2 diabetes and examination result on Visit 1: Blood glucose level of 126 mg/dL or higher, and HbA1c level of 6.5% or more (in fasting condition).
(3) Diagnosed with diabetes mellitus and examination result on Visit 1: Triglyceride level of 150 mg/dL or more, and less than 400 mg/dL (in fasting condition).
(4) Diagnosed with obesity and examination result on Visit 1: BMI of 25 kg/m2 or more.
3. Men and women aged 18 to 75 at the time of consent.
4. Patients who have received sufficient explanation for participating in this study, and who have obtained sufficient understanding and consent to the document of their own free will.
5. Patients who have the intention to use this investigational device appropriately under the guidance of the investigator, and the investigator judges that the patients are capable of improving their lifestyle, dietetic therapy, exercise therapy, etc., and self-managing each disease.
6. Patients who do not feel uncomfortable wearing a smartwatch device, except when taking a bath or charging the device.
7. Patients who have been using their smartphone for three months or more.

Exclude criteria

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.
11. Patients who have been diagnosed with secondary hypertension or strongly suspected of having secondary hypertension, e.g. ARR >= 200.
12. Patients who have been diagnosed with endocrine diseases such as hyperthyroidism, hypothyroidism, Cushing's syndrome, or hyperaldosteronism.
13. Patients who have moderate or severe heart disease (requiring outpatient treatment) or a history of it.
14. Patients who have an HbA1c level of 8.0% or higher within the past 12 weeks from the time of obtaining consent or the latest test results.
15. Patients who have been diagnosed with grade II essential hypertension (clinic systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher) within the past 12 weeks from the time of obtaining consent or the latest test results.
16. Patients who have an eGFR less than 45 mL/min/1.73m2 or urinary Alb/Cre 300 mg/gCre or higher within the past 12 weeks from the time of obtaining consent or the latest test results.
17. Patients who have been indicated to have a retinopathy more severe than pre-proliferative retinopathy.
18. Patients who have been instructed by the investigator that they cannot perform exercise therapy.
19. Patients who have been using corticosteroids or immunosuppressants chronically (injection, internal use, or inhalation).
20. Patients who intend to be hospitalized or have surgery for treatment during participation in this study.
21. Women who are pregnant, nursing, or have an intention to procreate.
22. Patients who have difficulty using a smartwatch device for a long time due to sensitive skin (metal allergies, etc.).
23. Patients who work night shifts.
24. Patients who have been judged by the investigator that they don't have enough time to improve their lifestyle due to working overtime or on days off for 45 hours or more per month, etc.
25. Patients who are judged by the investigator to not be an appropriate candidate for this study.

Related Information

• Primary Sponsor: Svensson Kishi Akiko
• Source(s) of Monetary Support: MED MIRAI, Inc.