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OpenTrials
Completed

NCT Number: NCT04496388

The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yu-Hsuan Chang

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Exercise

Behavioral

different type of exercise

No exercise intervention

Behavioral

No exercise intervention

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University

Other

Collaborators

  • National Cheng-Kung University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2020
Registry last updated
Mar 4, 2021

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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