Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients

Inha University Hospital

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT01051089

2009-459

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Lifestyle modification

Experimental group

Description:

supervised exercise with diet education

Treatment:

Behavioral: Lifestyle modification

Control

No Intervention group

Description:

Control (ordinary care with usual education)