Cohort of Obesity to Discover Individualized hEalthy Target

Cohort of Obesity to Discover Individualized hEalthy Target - Co-DIET

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056255

Enrollment

200

Registered

2024-12-01

Start date

2024-03-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a BMI of 25.0 or higher who meet any of the following criteria: Visceral fat area &gt

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. BMI more than 27.0 kg per m2 2. Having one or more obesity-related conditions as defined by the Japan Society for the Study of Obesity (impaired glucose tolerance, dyslipidemia, or hypertension). 3. Aged 18 years or older and under 75 years at the time of enrollment. 4. Provided written informed consent after receiving sufficient explanation and understanding the study's purpose.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The relationship between weight change rate and the change in the number of obesity-related health impairments at 36 months.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactTakumi Kitamoto

Chiba University Hospital Diabetes, Metabolism, and Endocrinology

t.kitamoto@chiba-u.jp+81432227171

Outcome results