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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Inha University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051089
First Posted: January 18, 2010
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Inha University Hospital
  Purpose
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 Intervention
Type 2 Diabetes Mellitus Behavioral: Lifestyle modification

Study Type: Interventional
Study Design: 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

Further study details as provided by Inha University Hospital:

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

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

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle modification
supervised exercise with diet education
Behavioral: Lifestyle modification
Exercise and diet education
No Intervention: Control
Control (ordinary care with usual education)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

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 Submitted: January 15, 2010
First Posted: January 18, 2010
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