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Completed

NCT Number: NCT01136096

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

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

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Physical activity promoting intervention

Behavioral
  • An interview with a physiotherapist
  • 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
  • An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
  • The daily record to check their body weight, exercise mode and duration
  • 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
  • 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

General instruction and education

Behavioral
  • 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
  • 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
  • Without individualized exercise program and interview with a physiotherapist

Other names: General advice, Medical education

Primary outcomes

  1. 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).

  2. Exercise behavior

    Time frame: Nine months after the start of the intervention

    • Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
    • Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

Secondary outcomes

  1. 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

  2. Metabolic components

    Time frame: Three, 6 and 9 months after the start of the intervention

    • Waist circumference (cm)
    • Fasting blood samples were centrifuged to obtain plasma for plasma triglycerides (TG) and high-density lipoprotein (HDL) levels in mg/dl
    • 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)
    • Systolic blood pressure (SBP) and dystolic blood pressure (DBP) in mmHg

  3. Physical fitness

    Time frame: Three, 6 and 9 months after the start of the intervention

    • Body composition (kg/m^2): Body mass index that was weight in kilograms divided by the square of height in meter
    • Flexibility (cm): Meausred by sit-and-reach test
    • Grip strength (Nm): Measured by Jamar handheld dynameter
    • Muscle endurance (times/min): Measured by sit-up test
    • Cardiopulmonary fitness (3-minute step test)

  4. 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

  5. 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)

  6. Exercise behavior

    Time frame: Three and 6 months after the start of the intervention

    • Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score
    • Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 3, 2010
Registry last updated
Jun 3, 2010

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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