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

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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