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Recruiting NCT06169033

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

Observational Obesity Type 2 Diabetes Mellitus Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity, Type 2 Diabetes Mellitus, Bariatric Surgery. Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Area under curve (AUC) of the weight loss prediction model after 1 year [Time frame: 1 year]
  • Area under curve (AUC) of the T2DM remission prediction model after 1 year [Time frame: 1 year]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Yuntao Nie — Beijing

Identifiers

NCT: NCT06169033 · CJBariatric002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗