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

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ClinicalTrials.gov Identifier: NCT01051089
Recruitment Status : Unknown
Verified January 2010 by Inha University Hospital.
Recruitment status was:  Recruiting
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Lifestyle modification Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
Study Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle modification
supervised exercise with diet education
Behavioral: Lifestyle modification
Exercise and diet education

No Intervention: Control
Control (ordinary care with usual education)



Primary Outcome Measures :
  1. HbA1c, serum adipokine levels [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 3 months ]
  2. Pulse wave velocity [ Time Frame: 3 months ]
  3. Insulin secretion and sensitivity [ Time Frame: 3 months ]
  4. VO2max [ Time Frame: 3 months ]


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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051089


Locations
Korea, Republic of
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Moonsuk Nam, MD, PhD    82-32-890-3689    namms@inha.ac.kr   
Principal Investigator: Moonsuk Nam, MD, PhD         
Sponsors and Collaborators
Inha University Hospital

Responsible Party: Moonsuk Nam, MD, PhD, Inha University School of Medicine, Inha University Hospital
ClinicalTrials.gov Identifier: NCT01051089     History of Changes
Other Study ID Numbers: 2009-459
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: January 2010

Keywords provided by Inha University Hospital:
type 2 diabetes mellitus
lifestyle modification

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases