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

July 8, 2025 updated by: Ki Hong Choi, Samsung Medical Center

Impact of Regular Physical Activity in Normal-Weight Individuals With Type 2 Diabetes and Abdominal Obesity: Nationwide Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

249247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abdominal obesity
Individuals were classified as having abdominal obesity.
Behavioral: Regular physical activity
Moderate-to-vigorous physical activity at least three times per week.
Behavioral: No regular physical activity
The group that did not engage in physical activity according to the guidelines
Without abdominal obesity
Individuals were classified as not having abdominal obesity.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: 10 years after diagnosed T2DM
Death from all cause
10 years after diagnosed T2DM
myocardial infarction
Time Frame: 10 years after diagnosed T2DM
MI with hospitalization
10 years after diagnosed T2DM
Ischemic stroke
Time Frame: 10 years after diagnosed T2DM
Ischemic stroke after diagnosed T2DM
10 years after diagnosed T2DM
Heart failure
Time Frame: 10 years after diagnosed T2DM
HF with hospitalization
10 years after diagnosed T2DM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 8, 2025

First Submitted That Met QC Criteria

July 8, 2025

First Posted (Actual)

July 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM_abdominalobesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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