Text Size

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:

U.S. FDA Resources

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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013