Effect of Regular Physical Activity in Normal-Weight Individuals With Type 2 Diabetes and Abdominal Obesity

Completed

• Conditions: Diabetes (DM); Physical Activity

• Registration Number: NCT07071545
• Lead Sponsor: Samsung Medical Center

Brief Summary

Individuals with T2DM accompanied by abdominal obesity tend to experience worse clinical outcomes. To identify modifiable factors that may improve these outcomes, the investigators conducted a retrospective cohort study using data from the Korean National Health Insurance Service (K-NHIS) database to evaluate the impact of regular physical activity.

Detailed Description

It is well established that patients with T2DM and abdominal obesity have worse clinical outcomes. This holds true even among individuals with a normal body weight but central (abdominal) obesity. In this study, the investigators aimed to determine whether engaging in regular physical activity (defined as vigorous exercise at least three times per week) is associated with improved clinical outcomes in normal-weight individuals with abdominal obesity. Specifically, we compared the incidence of MACCE between normal-weight patients with type 2 diabetes who had abdominal obesity and those who did not.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-09-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249247

Inclusion Criteria

• Patients who were newly diagnosed with T2DM and had a normal body weight at the time of diagnosis.

Exclusion Criteria

• Patients with any pre-existing diabetes-related complications
• Patients who were overweight or obese based on BMI criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerevrovascular events (MACCE)	10 years after diagnosed T2DM	Composite of all-cause death, myocardial infarction, ischemic stroke, heart failure

Secondary Outcome Measures

Name	Time	Method
All cause death	10 years after diagnosed T2DM	Death from all cause
myocardial infarction	10 years after diagnosed T2DM	MI with hospitalization
Ischemic stroke	10 years after diagnosed T2DM	Ischemic stroke after diagnosed T2DM
Heart failure	10 years after diagnosed T2DM	HF with hospitalization