NCT00763074

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
Last Updated

December 12, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

September 29, 2008

Last Update Submit

December 11, 2008

Conditions

Keywords

Intra-Abdominal FatAdipokinesExerciseDiet therapy

Study Arms (4)

Control

PLACEBO COMPARATOR

Conventional education of life style intervention for type 2 diabetes

Behavioral: Standard life style modification for type 2 diabetes

Diet

ACTIVE COMPARATOR

Dietary calorie restriction

Behavioral: Diet restriction

Exercise

ACTIVE COMPARATOR

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

Behavioral: Exercise

Diet and exercise

ACTIVE COMPARATOR

Intervention for both of exercise and diet

Behavioral: Diet and exercise

Interventions

Two session of education for exercise and diet. \----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30\~35kcal/day

Control

Education for diet and exercise every 2 weeks \----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day

Diet
ExerciseBEHAVIORAL

Education for diet and exercise every 2 weeks \----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day

Exercise

Education for diet and exercise every 2 weeks \----------- Exercise education like as exercise group and diet education like as diet group

Diet and exercise

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patient
  • BMI\>23kg/m2
  • Female

You may not qualify if:

  • The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2Motor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kyung Wan Min, Professor

    Eulji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

April 1, 2006

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

December 12, 2008

Record last verified: 2008-09