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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Physical activity promoting intervention
* Behavioral: General instruction and education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>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<br>* 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<br>* Other names: Exercise behavior modification;|
| Other: Control<br>Received oral instruction and written general education information without individualized exercise program | Behavioral: General instruction and education<br>* 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<br>* Other names: Medical education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma adiponectin level in μg/ml | 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 | Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score 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 | 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 | 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 | Three, 6 and 9 months after the start of the intervention | 
| Physical fitness | 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) | Three, 6 and 9 months after the start of the intervention | 
| Dietary intake | 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 | 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 | Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day | Three and 6 months after the start of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, physical activity, adiponectin, metabolic risks, exercise, primary prevention