Exercise, Insulin Resistance, Visceral Adipose TissueNCT04496388
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
A study testing exercise and No exercise intervention in people with Exercise, Insulin Resistance, Visceral Adipose Tissue, run by National Taiwan University at 1 site in Taiwan.
Trial summary
Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and metabolic syndrome. However, there is controversial data from prior studies to inform the type of exercise training recommendations. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Insulin Resistance, Visceral Adipose Tissue
- What is being tested?
- exercise and No exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2020to 31 Dec 2020
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 40 to 70 years old.
- without regular exercise in the past six years.
Who cannot join
- recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg.
- those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and metabolic syndrome. However, there is controversial data from prior studies to inform the type of exercise training recommendations.
Aim: The aim of this study will determine the differences of different type of exercise in the effects of reducing insulin resistance and visceral adipose tissue for community residents.
Read more
Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70 years old in Tainan. A total of at least 177 patients will randomly assign to the group of aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined with medium intensity interval training, and placebo. The participants in exercise group will received 12 weeks, 3 times per week program, including twice a week intervention guided by the intervenors, and once a week exercise guided by the video at home. All the exercise keeps moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).
Relevance to clinical practice: The research findings will help the clinical health works to know which type of exercise is the best choice in reducing insulin resistance and visceral adipose tissue in community residents, and can be promoted to the general public to reduce the prevalence of metabolic syndrome as well as prevent the root causes of ill health.
- Being tested
- exercise, No exercise intervention
- Medical subject headings
- Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
different type of exercise
No exercise interventionBehavioural
No exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise. Receives: Behavioral: exercise |
| Aerobic exercise combined with resistance exercise | Experimental | Aerobic exercise is lasting for nearly 20 minutes each time, and add resistance exercise for 20 minutes. Additional warm-up 10 minutes and stretching for 5 minutes. Receives: Behavioral: exercise |
| Aerobic exercise combined with interval training | Experimental | Aerobic exercise is lasting for nearly 20 minutes each time, and add moderal intensity interval training for 10 minutes. Additional warm-up 10 minutes and stretching for 15 minutes. Receives: Behavioral: exercise |
| Placebo | Placebo comparator | No exercise intervention. Receives: Behavioral: No exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral adipose tissue
measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.
Measured: time before intervention(T0) and after 12-weeks exercise intervention (T1)
insulin resistance
Blood samples.Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin （μU/mL）× glucose（mmol/L）/22.5). The insulin level and fasting sugar from blood sample will be checked to calculate the insulin resistance.
Measured: time before intervention(T0) and after 12-weeks exercise intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start7 Apr 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
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 Exercise, Insulin Resistance, Visceral Adipose TissueStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Responsible party
- Principal investigator, Yu-Hsuan Chang, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496388
- Sponsor's protocol ID
- 109-035
- Status last verified
- Mar 2021
- First submitted
- 25 Jul 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang YH, Shun SC, Chen MH, Chang YF. Feasibility of Different Exercise Modalities for Community-Dwelling Residents With Physical Inactivity: A Randomized Controlled Trial. J Nurs Res. 2023 Dec 1;31(6):e301. doi: 10.1097/jnr.0000000000000578.
PubMed 37883059
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
- ClinicalTrials.gov ID
- NCT04496388
- Acronym / sponsor ID
- 109-035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Aug 2020 (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.
Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and metabolic syndrome. However, there is controversial data from prior studies to inform the type of exercise training recommendations.
Aim: The aim of this study will determine the differences of different type of exercise in the effects of reducing insulin resistance and visceral adipose tissue for community residents.
Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70 years old in Tainan. A total of at least 177 patients will randomly assign to the group of aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined with medium intensity interval training, and placebo. The participants in exercise group will received 12 weeks, 3 times per week program, including twice a week intervention guided by the intervenors, and once a week exercise guided by the video at home. All the exercise keeps moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).
Relevance to clinical practice: The research findings will help the clinical health works to know which type of exercise is the best choice in reducing insulin resistance and visceral adipose tissue in community residents, and can be promoted to the general public to reduce the prevalence of metabolic syndrome as well as prevent the root causes of ill health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: exerciseAerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise. |
| Aerobic exercise combined with resistance exercise | Experimental | Behavioral: exerciseAerobic exercise is lasting for nearly 20 minutes each time, and add resistance exercise for 20 minutes. Additional warm-up 10 minutes and stretching for 5 minutes. |
| Aerobic exercise combined with interval training | Experimental | Behavioral: exerciseAerobic exercise is lasting for nearly 20 minutes each time, and add moderal intensity interval training for 10 minutes. Additional warm-up 10 minutes and stretching for 15 minutes. |
| Placebo | Placebo comparator | Behavioral: No exercise interventionNo exercise intervention. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults aged 40 to 70 years old.
- without regular exercise in the past six years.
Key exclusion criteria (2 listed)
- recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg.
- those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
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 |
|---|---|---|
| exercisedifferent type of exercise | Behavioural | Aerobic exercise, Aerobic exercise combined with interval training, Aerobic exercise combined with resistance exercise |
| No exercise interventionNo exercise intervention | Behavioural | Placebo |
Primary outcome
visceral adipose tissue
Time frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)
measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.
insulin resistance
Time frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)
Blood samples.Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin （μU/mL）× glucose（mmol/L）/22.5). The insulin level and fasting sugar from blood sample will be checked to calculate the insulin resistance.
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 4 Mar 2021.
- Derived from this study: PubMed 37883059Chang YH, Shun SC, Chen MH, Chang YF. Feasibility of Different Exercise Modalities for Community-Dwelling Residents With Physical Inactivity: A Randomized Controlled Trial. J Nurs Res. 2023 Dec 1;31(6):e301. doi: 10.1097/jnr.0000000000000578.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and No exercise intervention in people with Exercise, Insulin Resistance, Visceral Adipose Tissue, run by National Taiwan University at 1 site in Taiwan.
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 2 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
visceral adipose tissue (time frame: time before intervention(T0) and after 12-weeks exercise intervention (T1)). The study lists 2 primary outcomes in all. 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 NCT04496388, 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 4 Mar 2021.