obesity
Conditions
Interventions
[Standard treatment group without IoT] The target of body weight reduction is 3% (5% in case of morbid obesity (BMI is 35 kg/m2 or higher)) compared with the body weight at baseline. Patients record
Sponsors
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are as follows: 1) Patients with BMI of 25 kg/m2 or higher, and those who have two or more complications among six health disorders (diabetes mellitus or abnormal glucose tolerance, dyslipidemia, hypertension, hyperuricemia, liver steatosis, and obesity-related renal disease), which are some of the diagnostic criteria on obesity according to the Japan Society for the Study of Obesity 2) Male and female patients aged 18 years or older and younger than 75 years at obtaining consent 3) Written consent form to participate in the study signed by patients themselves after full explanation of this study and its ethical considerations 4) Patients who have smartphone compatible to application software used in this study (OMRON connect, Asken and Asfit) and who can manipulate and browse it by themselves
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows: 1) Secondary obesity (symptomatic obesity) 2) Patients who had a history of wasting disease or pathology with drastic weight loss within six months before the consent acquisition (such as severe infection disease, highly invasive surgery, malignant tumor, severe trauma, hyperthyroidism) 3) Patients with severe diabetic mellitus (HbA1c is 10% or higher) 4) Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher) 5) Patients with severe impairment in cardiorespiratory, renal or liver function to whom exercise therapy is not applicable 6) Patients with severe musculoskeletal impairment to whom exercise therapy is not applicable 7) Patients with unmanageable psychiatric disorder 8) Patients who are breastfeeding, pregnant, suspected of being pregnant or within 28 days of parturition 9) Patients who cannot provide written consent form or those who cannot understand study summary and obejective 10) patients who are considered unsuitable subjects by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of patients in whom body weight decreases and two or more health disorders are improved among which the patients had had at the enrollment at 12 months of treatment intervention to reduce body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy endpoints] 1. Ratio of patients in whom two or more health disorders are improved among six health disorders described in the primary outcome above at 24 months of treatment intervention to reduce body weight 2. Ratio of patients in whom dose of therapeutic agents for the health disorders described above are reduced at 12 months of treatment intervention 3. Ratio of patients in whom dose of therapeutic agents for the health disorders described above are reduced at 24 months of treatment intervention 4. Ratio of patients in whom one health disorders are improved among six health disorders described in the primary outcome above at 12 months of treatment intervention 5. Ratio of patients in whom one health disorders are improved among six health disorders described in the primary outcome above at 24 months of treatment intervention 6. Ratio of patients in whom the number of the health disorder becomes zero 7. Percent change of body weight 8. Percent change of visceral fat mass 9. Percent change of HbA1c 10. Percent change of serum lipids 11. Percent change of AST 12. Percent change of ALT 13. Percent change of gamma-GTP 14. Percent change of systolic and diastolic blood pressure 15. Percent change of Epworth Sleepiness Scale score 16. Percent change of questionnaire scores about patients' motivation for obesity management, joint pain, and menstrual abnormality 17. Dropout ratio of participating patients [Safety endpoints] 1. Frequency of adverse events 2. Frequency of sudden death, onset of cardiovascular events, onset of stroke, onset of malignant tumor, onset or aggravation of psychiatric disorder, and onset or aggravation of musculoskeletal impairment | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed