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

I

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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