Clinical trial NCT01136096: Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes
Official title: Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
physical activity
adiponectin
metabolic risks
exercise
primary prevention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2010-06-03
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Plasma adiponectin level in μg/ml
timeFrame: Nine months after the start of the intervention
measure: Exercise behavior
timeFrame: Nine months after the start of the intervention
Secondary outcomes:
measure: Insulin resistance
timeFrame: Three, 6 and 9 months after the start of the intervention
measure: Metabolic components
timeFrame: Three, 6 and 9 months after the start of the intervention
measure: Physical fitness
timeFrame: Three, 6 and 9 months after the start of the intervention
measure: Dietary intake
timeFrame: Three, 6 and 9 months after the start of the intervention
measure: Plasma adiponectin level in μg/ml
timeFrame: Three and 6 months after the start of the intervention
measure: Exercise behavior
timeFrame: Three and 6 months after the start of the intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Doctor
role: STUDY_DIRECTOR
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