Exercise and Diet in Type 2 Diabetic Women

This study has been completed.
Sponsor:
Information provided by:
Eulji University Hospital
ClinicalTrials.gov Identifier:
NCT00763074
First received: September 29, 2008
Last updated: December 11, 2008
Last verified: September 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Genders 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
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: NCT00763074

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

No publications provided

Responsible Party: Kyung Wan Min, Diabetes Center, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT00763074     History of Changes
Other Study ID Numbers: Obesity_2006_1
Study First Received: September 29, 2008
Last Updated: December 11, 2008
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014