Exercise and Diet in Type 2 Diabetic Women

Type 2 Diabetes Clinical Trial

Official title:

Clinical Trial of Exercise and Diet in Type 2 Diabetic Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763074
• Other study ID #: Obesity_2006_1
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: December 11, 2008
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: September 2008
• Source: Eulji University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Sensitivity
• Type 2 Diabetes

Intervention

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
• Diet restriction
Education for diet and exercise every 2 weeks ----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day
• Exercise
Education for diet and exercise every 2 weeks ----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day
• Diet and exercise
Education for diet and exercise every 2 weeks ----------- Exercise education like as exercise group and diet education like as diet group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eulji University Hospital