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

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01136096
First received: May 23, 2010
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus


Condition Intervention
Diabetes Mellitus
Behavioral: Physical activity promoting intervention
Behavioral: General instruction and education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Plasma adiponectin level in μg/ml [ Time Frame: Nine months after the start of the intervention ] [ Designated as safety issue: No ]
    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).

  • Exercise behavior [ Time Frame: Nine months after the start of the intervention ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
    plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated

  • Metabolic components [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
    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

  • Physical fitness [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
    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)

  • Dietary intake [ Time Frame: Three, 6 and 9 months after the start of the intervention ] [ Designated as safety issue: No ]
    Measured by 24-hour recall guestionnaire in kcal/kg/day

  • Plasma adiponectin level in μg/ml [ Time Frame: Three and 6 months after the start of the intervention ] [ Designated as safety issue: No ]
    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)

  • Exercise behavior [ Time Frame: Three and 6 months after the start of the intervention ] [ Designated as safety issue: No ]
    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


Enrollment: 216
Study Start Date: January 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136096

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
  More Information

Publications:

Responsible Party: Ying-Tai Wu/, National Taiwan University
ClinicalTrials.gov Identifier: NCT01136096     History of Changes
Other Study ID Numbers: 9261701067, DOH93-HP-1105, DOH94-HP-1105
Study First Received: May 23, 2010
Last Updated: June 2, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
diabetes
physical activity
adiponectin
metabolic risks
exercise
primary prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 26, 2014