UMIN-CTR Clinical Trial

Public title

Cohort of Obesity to Discover Individualized hEalthy Target

Acronym

Co-DIET

Scientific Title

Cohort of Obesity to Discover Individualized hEalthy Target

Scientific Title:Acronym

Co-DIET

Region

Japan

Condition

Patients with a BMI of 25.0 or higher who meet any of the following criteria:
Visceral fat area >= 100 cm^2 measured by abdominal CT
Impaired glucose tolerance (such as type 2 diabetes or abnormal glucose tolerance)
Dyslipidemia
Hypertension
Hyperuricemia or gout
Coronary artery disease (myocardial infarction or angina pectoris)
Cerebral infarction, cerebral thrombosis, or transient ischemic attack (TIA)
Fatty liver (non-alcoholic fatty liver disease, NAFLD)
Menstrual abnormalities or infertility
Sleep apnea syndrome (SAS)
Musculoskeletal disorders: osteoarthritis (knee, hip), spondylosis deformans, or osteoarthritis of the fingers
Obesity-related kidney disease

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The purpose of this study is to clarify the relationship between weight change due to weight-loss treatment and the number of obesity-related health impairments and to identify factors influencing changes in metabolic disorders using clinical, genomic, and transcriptomic data

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

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

Key secondary outcomes

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key 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.

Key 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.

Target sample size

200

Name of lead principal investigator

1st name	Takumi
Middle name
Last name	Kitamoto

Organization

Chiba University Hospital

Division name

Diabetes, Metabolism, and Endocrinology

Zip code

2608677

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

+81432227171

Email

t.kitamoto@chiba-u.jp

Name of contact person

1st name	Takumi
Middle name
Last name	Kitamoto

Organization

Chiba University Hospital

Division name

Diabetes, Metabolism, and Endocrinology

Zip code

260-8677

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

+81432227171

Homepage URL

Email

t.kitamoto@chiba-u.jp

Institute

Chiba University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital Clinical Research Ethics Review Committee

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan, 260-8677

Tel

+81432227171

Email

prc-jim@chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2024

Year

03

Month

15

Day

Date of IRB

2024

Year

03

Month

15

Day

Anticipated trial start date

2024

Year

03

Month

20

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Overview:
This study is conducted as a multicenter prospective observational cohort study targeting obese patients to evaluate the effects of weight-loss treatment on improving health impairments.

1. Target Disease:
Obesity with BMI more than 27.0 and at least one comorbidity, such as impaired glucose tolerance, dyslipidemia, or hypertension.
2. Study Objective:
To evaluate the efficacy and safety of weight-loss treatment and analyze genetic and transcriptomic data from liver and adipose tissues to identify markers for personalized medical care.
3. Observation Period:
Up to 36 months, with data collected at 6, 12, 24, and 36 months.
4. Observation Parameters:
Primary Outcome: To evaluate the relationship between weight change rate and change in the number of health impairments.
Secondary Outcomes: To observe changes in HbA1c, serum lipids, blood pressure, liver and kidney function, body fat mass, and visceral fat mass.
5. Data Collection:
Data will be collected through routine clinical examinations, including blood tests, imaging studies, and patient questionnaires.
6. Ethical Considerations:
Ethical approval will be obtained from the Institutional Review Board, ensuring participant safety and data confidentiality.
7. Study Design:
Observational study (mixed prospective and retrospective), single-arm design.

Registered date

2024

Year

11

Month

24

Day

Last modified on

2025

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064169