Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
| Verified date | January 2010 |
| Source | Inha University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - age 25 or older, - type 2 diabetes mellitus, - HbA1c 6.5-10% BMI 23 or higher. Exclusion Criteria: - type 1 diabetes, - recent (within 3 months) cardiovascular event, - severe hepatic or renal dysfunction, - insulin use, - glucocorticoid use. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Inha University Hospital | Incheon |
| Lead Sponsor | Collaborator |
|---|---|
| Inha University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c, serum adipokine levels | 3 months | No | |
| Secondary | Body composition | 3 months | No | |
| Secondary | Pulse wave velocity | 3 months | No | |
| Secondary | Insulin secretion and sensitivity | 3 months | No | |
| Secondary | VO2max | 3 months | No |
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