Exercise and Diet in Type 2 Diabetic Women

Clinical Trial of Exercise and Diet in Type 2 Diabetic Women

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Insulin Sensitivity
• Intervention / Treatment: Behavioral: Standard life style modification for type 2 diabetes; Behavioral: Diet restriction; Behavioral: Exercise; Behavioral: Diet and exercise

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Collaborators and Investigators

• Sponsor: Eulji University Hospital
• Investigators: Principal Investigator: Kyung Wan Min, Professor, Eulji University

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2008
• Last Update Submitted That Met QC Criteria: December 11, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Exercise; Adipokines; Diet therapy; Intra-Abdominal Fat
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: Obesity_2006_1