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.

Study Overview

• Status: Completed
• Conditions: Exercise, Insulin Resistance, Visceral Adipose Tissue
• Intervention / Treatment: Behavioral: exercise; Behavioral: No exercise intervention

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Yu-Hsuan Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise; Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise.	Behavioral: exercise; different type of exercise
Experimental: Aerobic exercise combined with resistance exercise; 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.	Behavioral: exercise; different type of exercise
Experimental: Aerobic exercise combined with interval training; 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.	Behavioral: exercise; different type of exercise
Placebo Comparator: Placebo; No exercise intervention.	Behavioral: No exercise intervention; No exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: National Taiwan University
• Collaborators: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 109-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No