Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)

Recruiting

• Conditions: Obesity; Type 2 Diabetes Mellitus; Bariatric Surgery

• Registration Number: NCT06169033
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Study Start: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• BMI>27.5kg/m2; Type 2 diabetes mellitus; Patients who will undergo bariatric surgery

Exclusion Criteria

• Patients without abdominal CT scan; Patients did not undergo sleeve gastrectomy or Roux-en-Y gastric bypass.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC) of the T2DM remission prediction model after 1 year	1 year	This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 1 year.
Area under curve (AUC) of the weight loss prediction model after 1 year	1 year	This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 1 year.

Secondary Outcome Measures

Name	Time	Method
Area under curve (AUC) of the weight regain model	5 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of weight regain.
Area under curve (AUC) of the weight loss prediction model after 3 years	3 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 3 years.
Area under curve (AUC) of the T2DM relapse model	5 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of T2DM relapse.
Area under curve (AUC) of the weight loss prediction model after 5 years	5 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of inadequate weight loss after 5 years.
Area under curve (AUC) of the T2DM remission prediction model after 3 years	3 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 3 years.
Area under curve (AUC) of the T2DM remission prediction model after 5 years	5 years	This metric shows the discriminatory ability of the radiomic model to predict the probability of remission of T2DM after 5 years.

Trial Locations

Locations (1)

Yuntao Nie; 🇨🇳 Beijing, China