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Completed

NCT Number: NCT07071545

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

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.

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Key information

Conditions

Diabetes (DM) Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular Physical Activity

Behavioral

Moderate-to-vigorous physical activity at least three times per week.

No regular physical activity

Behavioral

The group that did not engage in physical activity according to the guidelines

Primary outcomes

  1. 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

Secondary outcomes

  1. All cause death

    Time frame: 10 years after diagnosed T2DM

    Death from all cause

  2. myocardial infarction

    Time frame: 10 years after diagnosed T2DM

    MI with hospitalization

  3. Ischemic stroke

    Time frame: 10 years after diagnosed T2DM

    Ischemic stroke after diagnosed T2DM

  4. Heart failure

    Time frame: 10 years after diagnosed T2DM

    HF with hospitalization

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: PA-NormalWtDM

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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