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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Lifestyle modification

• Registration Number: NCT01051089
• Lead Sponsor: Inha University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Last Update Submitted: 2010-01-15
• Study First Posted: 2010-01-18
• Last Update Posted: 2010-01-18
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 25 or older,
• type 2 diabetes mellitus,
• HbA1c 6.5-10% BMI 23 or higher.

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Exclusion Criteria

• type 1 diabetes,
• recent (within 3 months) cardiovascular event,
• severe hepatic or renal dysfunction,
• insulin use,
• glucocorticoid use.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle modification	Lifestyle modification	supervised exercise with diet education

Primary Outcome Measures

Name	Time	Method
HbA1c, serum adipokine levels	3 months

Secondary Outcome Measures

Name	Time	Method
Body composition	3 months
Pulse wave velocity	3 months
Insulin secretion and sensitivity	3 months
VO2max	3 months

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of