Diabetes (DM)PA-NormalWtDMNCT07071545
Effect of Regular Physical Activity in Normal-Weight Individuals With Type 2 Diabetes and Abdominal Obesity
An observational study of Diabetes (DM) and Physical Activity, run by Samsung Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes (DM), Physical Activity
- What is being tested?
- Regular physical activity and No regular physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 249,247 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were newly diagnosed with T2DM and had a normal body weight at the time of diagnosis.
Who may be able to join
- Patients who were newly diagnosed with T2DM and had a normal body weight at the time of diagnosis.
Who cannot join
- Patients with any pre-existing diabetes-related complications
- Patients who were overweight or obese based on BMI criteria
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes (DM), Physical Activity
- Being tested
- Regular physical activity, No regular physical activity
- Keywords
- abdominal obesity, physical activity, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular physical activityBehavioural
Moderate-to-vigorous physical activity at least three times per week.
No regular physical activityBehavioural
The group that did not engage in physical activity according to the guidelines
| Study group | Role | What they receive |
|---|---|---|
| Abdominal obesity | Individuals were classified as having abdominal obesity. Receives: Behavioral: Regular physical activity; Behavioral: No regular physical activity | |
| Without abdominal obesity | Individuals were classified as not having abdominal obesity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerevrovascular events (MACCE)
Composite of all-cause death, myocardial infarction, ischemic stroke, heart failure
Measured: 10 years after diagnosed T2DM
Secondary outcomes (4)
All cause death
Death from all cause
Measured: 10 years after diagnosed T2DM
myocardial infarction
MI with hospitalization
Measured: 10 years after diagnosed T2DM
Ischemic stroke
Ischemic stroke after diagnosed T2DM
Measured: 10 years after diagnosed T2DM
Heart failure
HF with hospitalization
Measured: 10 years after diagnosed T2DM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jan 2010
- Primary completion30 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 249,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071545
- Sponsor's protocol ID
- DM_abdominalobesity
- Acronym
- PA-NormalWtDM
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim O, Park YH, Kim SY, Lee M, Hahn W, Kim CH, Kang D, Choi KH. Physical Activity and Cardiovascular Risk in Type 2 Diabetes With Normal Body Mass Index and Abdominal Obesity: A Nationwide Cohort Study. J Am Heart Assoc. 2026 Oct 23:e052821. doi: 10.1161/JAHA.126.052821. Online ahead of print.
PubMed 42924855
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regular Physical Activity in Normal-Weight Individuals With Type 2 Diabetes and Abdominal Obesity: Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT07071545
- Acronym / sponsor ID
- PA-NormalWtDM / DM_abdominalobesity
- Conditions
- Diabetes (DM), Physical Activity
- Keywords
- abdominal obesity, physical activity, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249,247 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal obesity | – | Behavioral: Regular physical activity, Behavioral: No regular physical activityIndividuals were classified as having abdominal obesity. |
| Without abdominal obesity | – | –Individuals were classified as not having abdominal obesity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were newly diagnosed with T2DM and had a normal body weight at the time of diagnosis.
Key inclusion criteria (1 listed)
- Patients who were newly diagnosed with T2DM and had a normal body weight at the time of diagnosis.
Key exclusion criteria (2 listed)
- Patients with any pre-existing diabetes-related complications
- Patients who were overweight or obese based on BMI criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular physical activityModerate-to-vigorous physical activity at least three times per week. | Behavioural | Abdominal obesity |
| No regular physical activityThe group that did not engage in physical activity according to the guidelines | Behavioural | Abdominal obesity |
Primary outcome
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
4 secondary outcomes
All cause death
Time frame: 10 years after diagnosed T2DM
myocardial infarction
Time frame: 10 years after diagnosed T2DM
Ischemic stroke
Time frame: 10 years after diagnosed T2DM
Heart failure
Time frame: 10 years after diagnosed T2DM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 42924855Kim O, Park YH, Kim SY, Lee M, Hahn W, Kim CH, Kang D, Choi KH. Physical Activity and Cardiovascular Risk in Type 2 Diabetes With Normal Body Mass Index and Abdominal Obesity: A Nationwide Cohort Study. J Am Heart Assoc. 2026 Oct 23:e052821. doi: 10.1161/JAHA.126.052821. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Physical Activity, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerevrovascular events (MACCE) (time frame: 10 years after diagnosed T2DM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07071545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.