Exercise and Diet in Type 2 Diabetic Women

December 11, 2008 updated by: Eulji University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Eulji University Hospital

Investigators

  • Principal Investigator: Kyung Wan Min, Professor, Eulji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity_2006_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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