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

JRCT ID: jRCTs032210304

Registered date:10/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metabolic syndrome-based hypertension, dyslipidemia, diabetes, and obesity
• Date of first enrollment: 21/09/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

MED MIRAI use group: Continue to use MED MIRAI and wearable devices for 12 weeks. Receive lifestyle-related advice from a doctor using the application's doctor screen at the time of doctor visits.
MED MIRAI non-use group: No use of MED MIRAI. Only wearable devices will continue to be used for 12 weeks. Get general lifestyle advice from your doctor at the time of doctor visits.

Outcome(s)

• Primary Outcome: Composite endpoint based on each change of BMI (kg / m2), body weight (kg), abdominal circumference (cm), body fat ratio (%), visceral fat area (cm2), fasting blood glucose level (mg / dL), HbA1c (12 weeks from baseline) %), GA (%), systolic and diastolic blood glucose (mmHg) (double value average), HDL cholesterol (mg / dL), LDL-cholesterol calculated value (mg / dL) and triglyceride (mg / dL)

Secondary Outcome

1) Changes in the following items at 12 weeks from baseline
BMI (kg / m2), body weight (kg), abdominal circumference (cm), body fat ratio (%), visceral fat area (cm2), fasting blood glucose level (mg / dL), HbA1c (%), GA (%) , Systolic and diastolic blood glucose (mmHg) (double value average), total cholesterol (mg / dL), HDL-cholesterol (mg / dL), LDL-cholesterol calculated value (mg / dL) and triglyceride (mg / dL).
(2) Changes in lifestyle (nutrition, activity, sleep, stress, smoking, and drinking)
by using MED MIRAI
(3) Changes in self-management using surveys
Patient satisfaction survey, doctor survey, behavioral change stage change, and self-management survey

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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
onsent
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)

Exclude criteria

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.

Related Information

• Primary Sponsor: Nagashima Hirotaka
• Secondary Sponsor: Akiko Kishi,Graduate School of Engineering, The University of Tokyo,
• Source(s) of Monetary Support: MED MIRAI,Inc.