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

Primary Purpose

Exercise, Insulin Resistance, Visceral Adipose Tissue

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
No exercise intervention
Sponsored by
National Taiwan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise, Insulin Resistance, Visceral Adipose Tissue

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yu-Hsuan Chang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Aerobic exercise

Aerobic exercise combined with resistance exercise

Aerobic exercise combined with interval training

Placebo

Arm Description

Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after 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.

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.

No exercise intervention.

Outcomes

Primary Outcome Measures

visceral adipose tissue
measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2020
Last Updated
March 2, 2021
Sponsor
National Taiwan University
Collaborators
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04496388
Brief Title
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
Official Title
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University
Collaborators
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Insulin Resistance, Visceral Adipose Tissue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise is lasting for nearly 50 minutes each time, including warm-up and stretching for 10 minutes after exercise.
Arm Title
Aerobic exercise combined with resistance exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic exercise combined with interval training
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
different type of exercise
Intervention Type
Behavioral
Intervention Name(s)
No exercise intervention
Intervention Description
No exercise intervention
Primary Outcome Measure Information:
Title
visceral adipose tissue
Description
measured by the body composition analyzer, which uses bioelectrical impedance analysis to estimate body composition.
Time Frame
time before intervention(T0) and after 12-weeks exercise intervention (T1)
Title
insulin resistance
Description
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 Frame
time before intervention(T0) and after 12-weeks exercise intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Yu-Hsuan Chang
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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