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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Inha University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01051089
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Inha University Hospital:

Primary Outcome Measures:
  • HbA1c, serum adipokine levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Insulin secretion and sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • VO2max [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 15, 2010
Last Updated: January 15, 2010
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014