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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Physical activity promoting intervention; Behavioral: General instruction and education

• Registration Number: NCT01136096
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2010-05-23
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Physical activity promoting intervention	To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model
Control	General instruction and education	Received oral instruction and written general education information without individualized exercise program

Primary Outcome Measures

Name	Time	Method
Plasma adiponectin level in μg/ml	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).
Exercise behavior	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

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	Three, 6 and 9 months after the start of the intervention	plasma inulin level (μU/ml) meausred by AxSYM with HOMA-IR was caculated
Metabolic components	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
Physical fitness	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)
Dietary intake	Three, 6 and 9 months after the start of the intervention	Measured by 24-hour recall guestionnaire in kcal/kg/day
Plasma adiponectin level in μg/ml	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)
Exercise behavior	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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan