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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04282837
Other study ID # Obesity Reclassification
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date June 20, 2020

Study information

Verified date June 2020
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to employ or develop computational modeling techniques for the precise reclassification of obesity into subgroups. Clinical features, risks of noncommunicable diseases, as well as weight loss effects of bariatric surgery will also be studied and compared within the subgroups.


Recruitment information / eligibility

Status Completed
Enrollment 2495
Est. completion date June 20, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients with overweight/obesity

2. Patients with normal weight as controls

Exclusion Criteria:

1. had ever been performed with a bariatric surgery before the study's first visit is scheduled;

2. had taken exogenous insulin, medication that affects glucose metabolism, or uric acid drugs currently;

3. being diagnosed with type 1 diabetes, secondary diabetes, hereditary disease, or severe disease (e.g. malignant tumor, heart failure, liver failure, etc.);

4. in gestation of lactation;

5. did not have the complete data for model;

6. for normal-weight controls, patients with diabetes or hyperuricemia were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
AI classification of patients with obesity
Computational modeling techniques will be used for the precise reclassification of obesity into four subgroups, several variables according to the clinical experience and the modeling results will be selected for the cluster analysis.

Locations

Country Name City State
China Shanghai Tenth People's Hospital Shanghai Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital Shanghai East Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Third People's Hospital of Chengdu, University of Pittsburgh

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic classification of patients with obesity using machine learning baseline
Secondary Metabolic features in patients of different subgroups baseline
Secondary Risks for noncommunicable disease in patients of different subgroups baseline
Secondary Effect of bariatric surgery in patients of different subgroups 1 year after bariatric surgery
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