NCT06169033

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

December 5, 2023

Last Update Submit

July 31, 2025

Conditions

ObesityType 2 Diabetes MellitusBariatric Surgery

Keywords

ObesityType 2 Diabetes MellitusRadiomicsAbdominal adiposeSubcutaneous adiposePrediction model

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Area under curve (AUC) of the weight loss prediction model after 3 years

    3 years

  • Area under curve (AUC) of the T2DM remission prediction model after 3 years

    3 years

  • Area under curve (AUC) of the weight loss prediction model after 5 years

    5 years

  • Area under curve (AUC) of the T2DM remission prediction model after 5 years

    5 years

  • Area under curve (AUC) of the weight regain model

    5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuntao Nie

Beijing, 100029, China

RECRUITING

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Yuntao Nie, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuntao Nie, M.D.

CONTACT

+8618611835860nytnyt1231@163.com

Hua Meng, M.D.

CONTACT

+8618611457779menghuade@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 3, 2025

Record last verified: 2025-07

Locations

CN(1)