UMIN ID: UMIN000056255
Registered date:01/12/2024
Cohort of Obesity to Discover Individualized hEalthy Target
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Obesity with BMI more than 27.0 and one or more comorbidities, such as impaired glucose tolerance, dyslipidemia, or hypertension. |
| Date of first enrollment | 2024/03/20 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The relationship between weight change rate and the change in the number of obesity-related health impairments at 36 months. |
|---|---|
| Secondary Outcome | 1. Weight change rate at 6, 12, 24, and 36 months. 2. Changes in HbA1c, serum lipids, systolic and diastolic blood pressure, liver function (AST, ALT, G-GTP), and kidney function (eGFR, mAlb, etc.) at 6, 12, 24, and 36 months. 3. Changes in visceral fat mass, body fat mass, and lean body mass. 4. Frequency of adverse events (cardiovascular events, malignancies, mental disorders, etc.) as safety outcomes. |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients meeting any of the following criteria will be excluded: 1. Secondary obesity (symptomatic obesity). 2. A history of conditions causing severe weight loss within the past 6 months (e.g., severe infections, major surgeries, malignancies, severe trauma, or hyperthyroidism). 3. Severe diabetes with HbA1c more than 10 percent. 4. Treatment-resistant hypertension with systolic blood pressure more than 180 mmHg. 5. Severe cardiac, pulmonary, renal, hepatic, or musculoskeletal conditions that contraindicate exercise therapy. 6. Unmanageable mental health disorders. 7. Pregnancy, potential pregnancy, within 28 days postpartum, or breastfeeding. 8. Unable to understand the study's purpose or provide consent. 9. Considered unsuitable for safe participation by the principal or sub-investigators. |
Related Information
| Primary Sponsor | Chiba University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology (MEXT) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takumi Kitamoto |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8677 |
| Telephone | +81432227171 |
| t.kitamoto@chiba-u.jp | |
| Affiliation | Chiba University Hospital Diabetes, Metabolism, and Endocrinology |
| scientific contact | |
| Name | Takumi Kitamoto |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan |
| Telephone | +81432227171 |
| t.kitamoto@chiba-u.jp | |
| Affiliation | Chiba University Hospital Diabetes, Metabolism, and Endocrinology |