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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169033
• Other study ID #: CJBariatric002
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: China-Japan Friendship Hospital
• Contact: Yuntao Nie, M.D.
• Phone: +8618611835860
• Email: nytnyt1231[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
China	Yuntao Nie	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years