ObesityNCT06169033
Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)
An observational study of Obesity and Type 2 Diabetes Mellitus, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus, Bariatric Surgery
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Obese patients with type 2 diabetes who will undergo bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) and receive abdominal CT scan will be included in the study.
Who may be able to join
- BMI>27.5kg/m2; Type 2 diabetes mellitus; Patients who will undergo bariatric surgery
Who cannot join
- Patients without abdominal CT scan; Patients did not undergo sleeve gastrectomy or Roux-en-Y gastric bypass.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yuntao Nie
Beijing, 100029
Yuntao Nie, M.D., +8618611835860, nytnyt1231@163.com
Hua Meng, M.D., +8618611457779, menghuade@hotmail.com
About this study
Using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery.
Read the detailed description
In this study, the investigator intend to collect abdominal CT from patients who are proposed to undergo bariatric surgery, to extract the radiomics of intra-abdominal fat and subcutaneous fat, and to establish a prediction model for predicting the efficacy of weight loss and remission of type 2 diabetes mellitus at 1 year, 3 years, and 5 years postoperatively, in conjunction with the clinical data.
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Bariatric Surgery
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Radiomics, Abdominal adipose, Subcutaneous adipose, Prediction model
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of the weight loss prediction model after 1 year
This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 1 year.
Measured: 1 year
Area under curve (AUC) of the T2DM remission prediction model after 1 year
This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 1 year.
Measured: 1 year
Secondary outcomes (6)
Area under curve (AUC) of the weight loss prediction model after 3 years
This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 3 years.
Measured: 3 years
Area under curve (AUC) of the T2DM remission prediction model after 3 years
This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 3 years.
Measured: 3 years
Area under curve (AUC) of the weight loss prediction model after 5 years
This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 5 years.
Measured: 5 years
Area under curve (AUC) of the T2DM remission prediction model after 5 years
This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 5 years.
Measured: 5 years
Area under curve (AUC) of the weight regain model
This metric shows the discriminatory ability of the radiomic model to predict the probability of weight regain.
Measured: 5 years
Area under curve (AUC) of the T2DM relapse model
This metric shows the discriminatory ability of the radiomic model to predict the probability of T2DM relapse.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuntao Nie, China-Japan Friendship Hospital
- Investigators
- Yuntao Nie, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169033
- Sponsor's protocol ID
- CJBariatric002
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject information involves medical and personal privacy and access is subject to the consent of the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)
- ClinicalTrials.gov ID
- NCT06169033
- Acronym / sponsor ID
- CJBariatric002
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Bariatric Surgery
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Radiomics, Abdominal adipose, Subcutaneous adipose, Prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery.
Detailed description
In this study, the investigator intend to collect abdominal CT from patients who are proposed to undergo bariatric surgery, to extract the radiomics of intra-abdominal fat and subcutaneous fat, and to establish a prediction model for predicting the efficacy of weight loss and remission of type 2 diabetes mellitus at 1 year, 3 years, and 5 years postoperatively, in conjunction with the clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Obese patients with type 2 diabetes who will undergo bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) and receive abdominal CT scan will be included in the study.
Key inclusion criteria (1 listed)
- BMI>27.5kg/m2; Type 2 diabetes mellitus; Patients who will undergo bariatric surgery
Key exclusion criteria (1 listed)
- Patients without abdominal CT scan; Patients did not undergo sleeve gastrectomy or Roux-en-Y gastric bypass.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under curve (AUC) of the weight loss prediction model after 1 year
Time frame: 1 year
This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 1 year.
Area under curve (AUC) of the T2DM remission prediction model after 1 year
Time frame: 1 year
This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 1 year.
6 secondary outcomes
Area under curve (AUC) of the weight loss prediction model after 3 years
Time frame: 3 years
Area under curve (AUC) of the T2DM remission prediction model after 3 years
Time frame: 3 years
Area under curve (AUC) of the weight loss prediction model after 5 years
Time frame: 5 years
Area under curve (AUC) of the T2DM remission prediction model after 5 years
Time frame: 5 years
Area under curve (AUC) of the weight regain model
Time frame: 5 years
Area under curve (AUC) of the T2DM relapse model
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided. Subject information involves medical and personal privacy and access is subject to the consent of the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuntao Nie, M.D. principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes Mellitus, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuntao Nie, M.D. (+8618611835860, nytnyt1231@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) of the weight loss prediction model after 1 year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.