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Exercise and Diet in Type 2 Diabetic Women

Primary Purpose

Insulin Sensitivity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard life style modification for type 2 diabetes
Diet restriction
Exercise
Diet and exercise
Sponsored by
Eulji University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Sensitivity focused on measuring Intra-Abdominal Fat, Adipokines, Exercise, Diet therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Control

    Diet

    Exercise

    Diet and exercise

    Arm Description

    Conventional education of life style intervention for type 2 diabetes

    Dietary calorie restriction

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

    Intervention for both of exercise and diet

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2008
    Last Updated
    December 11, 2008
    Sponsor
    Eulji University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00763074
    Brief Title
    Exercise and Diet in Type 2 Diabetic Women
    Official Title
    Clinical Trial of Exercise and Diet in Type 2 Diabetic Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eulji University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Sensitivity, Type 2 Diabetes
    Keywords
    Intra-Abdominal Fat, Adipokines, Exercise, Diet therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Conventional education of life style intervention for type 2 diabetes
    Arm Title
    Diet
    Arm Type
    Active Comparator
    Arm Description
    Dietary calorie restriction
    Arm Title
    Exercise
    Arm Type
    Active Comparator
    Arm Description
    Encourage to increase exercise amount: more than 60min's of exercise with moderate activity level two times per day
    Arm Title
    Diet and exercise
    Arm Type
    Active Comparator
    Arm Description
    Intervention for both of exercise and diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard life style modification for type 2 diabetes
    Intervention Description
    Two session of education for exercise and diet. ----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30~35kcal/day
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet restriction
    Intervention Description
    Education for diet and exercise every 2 weeks ----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Education for diet and exercise every 2 weeks ----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet and exercise
    Intervention Description
    Education for diet and exercise every 2 weeks ----------- Exercise education like as exercise group and diet education like as diet group

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyung Wan Min, Professor
    Organizational Affiliation
    Eulji University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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