Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- Taipei Medical University
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- blood sugar
- Last Updated
- 8 years ago
Overview
Brief Summary
The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.
Detailed Description
The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •40 years old or over
- •elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
Exclusion Criteria
- •having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years
- •having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment
- •receiving corticosteroids, androgens, estrogen containing compounds
- •who had dietary problem
- •pregnant women
- •who joined other health intervention study in one year.
Outcomes
Primary Outcomes
blood sugar
Time Frame: 3 month, 6 month and 12-month follow up
changes in fasting glucose and glycated hemoglobin
Secondary Outcomes
- body weight(3 month, 6 month and 12-month follow up)
- BMI(3 month, 6 month and 12-month follow up)
- Metabolic syndrome(3 month, 6 month and 12-month follow up)