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
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.
- 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.