Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes

June 2, 2010 updated by: National Taiwan University Hospital
Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial was designed to investigate whether a home-based exercise could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin resistance, metabolic components and physical fitness) in subjects with at least a diabetic risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a control group or a home-based exercise group. All participants were evaluated for outcome measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the intervention.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • At least one of the following criteria as following: BMI >=24 kg/m*m, hypertension, dyslipidemia, fist-degree relatives of parents with type 2 diabetes, impaired glucose tolerance, gestational diabetes and delivering a babt weighing >=4.0 kg
  • Ability of understanding Chinese or Taiwanese

Exclusion Criteria:

  • Diabetes
  • Receiving treatment with insulin or oral hypoglycemic agents
  • Any other serious illness that prohibit them to undertake fitness evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model
Behavioral: Physical activity promoting intervention
  1. An interview with a physiotherapist
  2. An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home
  3. An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
  4. The daily record to check their body weight, exercise mode and duration
  5. Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details
  6. Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule
Other Names:
  • Home-based exercise
  • Exercise behavior modification
Other: Control
Received oral instruction and written general education information without individualized exercise program
Behavioral: General instruction and education
  1. Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic
  2. Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule
  3. Without individualized exercise program and interview with a physiotherapist
Other Names:
  • General advice
  • Medical education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma adiponectin level in μg/ml
Time Frame: Nine months after the start of the intervention
Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA).
Nine months after the start of the intervention
Exercise behavior
Time Frame: Nine months after the start of the intervention
  1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
  2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day
Nine months after the start of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: Three, 6 and 9 months after the start of the intervention
plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated
Three, 6 and 9 months after the start of the intervention
Metabolic components
Time Frame: Three, 6 and 9 months after the start of the intervention
  1. Waist circumference (cm)
  2. Fasting blood samples were centrifuged to obtain plasma for plasma triglycerides (TG) and high-density lipoprotein (HDL) levels in mg/dl
  3. Plasma fasting glucose (FG) levels were measured in mg/dl by using the glucose oxidase membrane/hydrogen peroxide electrode method with the Antsense II analyzer (Bayer-Sankyo Co., Tokyo, Japan)
  4. Systolic blood pressure (SBP) and dystolic blood pressure (DBP) in mmHg
Three, 6 and 9 months after the start of the intervention
Physical fitness
Time Frame: Three, 6 and 9 months after the start of the intervention
  1. Body composition (kg/m^2): Body mass index that was weight in kilograms divided by the square of height in meter
  2. Flexibility (cm): Meausred by sit-and-reach test
  3. Grip strength (Nm): Measured by Jamar handheld dynameter
  4. Muscle endurance (times/min): Measured by sit-up test
  5. Cardiopulmonary fitness (3-minute step test)
Three, 6 and 9 months after the start of the intervention
Dietary intake
Time Frame: Three, 6 and 9 months after the start of the intervention
Measured by 24-hour recall guestionnaire in kcal/kg/day
Three, 6 and 9 months after the start of the intervention
Plasma adiponectin level in μg/ml
Time Frame: Three and 6 months after the start of the intervention
Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA)
Three and 6 months after the start of the intervention
Exercise behavior
Time Frame: Three and 6 months after the start of the intervention
  1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
  2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day
Three and 6 months after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

  • Study Director: Ying-Tai Wu, Doctor, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

May 23, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9261701067
  • DOH93-HP-1105 (Other Grant/Funding Number: Taiwan: Department of Health)
  • DOH94-HP-1105 (Other Grant/Funding Number: Taiwan: Department of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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