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Exercise and Diet in Type 2 Diabetic Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763074
First Posted: September 30, 2008
Last Update Posted: December 12, 2008
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:
Eulji University Hospital
  Purpose
The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.

Condition Intervention
Insulin Sensitivity Type 2 Diabetes Behavioral: Standard life style modification for type 2 diabetes Behavioral: Diet restriction Behavioral: Exercise Behavioral: Diet and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Exercise and Diet in Type 2 Diabetic Women

Resource links provided by NLM:


Further study details as provided by Eulji University Hospital:

Enrollment: 70
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Conventional education of life style intervention for type 2 diabetes
Behavioral: Standard life style modification for type 2 diabetes

Two session of education for exercise and diet.

----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30~35kcal/day

Active Comparator: Diet
Dietary calorie restriction
Behavioral: Diet restriction

Education for diet and exercise every 2 weeks

----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day

Active Comparator: Exercise
Encourage to increase exercise amount: more than 60min's of exercise with moderate activity level two times per day
Behavioral: Exercise

Education for diet and exercise every 2 weeks

----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day

Active Comparator: Diet and exercise
Intervention for both of exercise and diet
Behavioral: Diet and exercise

Education for diet and exercise every 2 weeks

----------- Exercise education like as exercise group and diet education like as diet group


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patient
  • BMI>23kg/m2
  • Female

Exclusion Criteria:

  • The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis
  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): NCT00763074


Sponsors and Collaborators
Eulji University Hospital
Investigators
Principal Investigator: Kyung Wan Min, Professor Eulji University
  More Information

Responsible Party: Kyung Wan Min, Diabetes Center, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT00763074     History of Changes
Other Study ID Numbers: Obesity_2006_1
First Submitted: September 29, 2008
First Posted: September 30, 2008
Last Update Posted: December 12, 2008
Last Verified: September 2008

Keywords provided by Eulji University Hospital:
Intra-Abdominal Fat
Adipokines
Exercise
Diet therapy

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases