Exercise, Insulin Resistance, Visceral Adipose Tissue Clinical Trial
Official title:
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
| NCT number | NCT04496388 |
| Other study ID # | 109-035 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 7, 2020 |
| Est. completion date | December 31, 2020 |
| Verified date | March 2021 |
| Source | National Taiwan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years to 70 Years |
| Eligibility | Inclusion Criteria: - adults aged 40 to 70 years old. - without regular exercise in the past six years. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Yu-Hsuan Chang | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University | National Cheng-Kung University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | visceral adipose tissue | measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition. | time before intervention(T0) and after 12-weeks exercise intervention (T1) | |
| Primary | 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. | time before intervention(T0) and after 12-weeks exercise intervention (T1) |