NCT01542775

Brief Summary

The purpose of this study is to examine the effects of exercise on diverse cardiometabolic risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

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

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

February 20, 2012

Last Update Submit

March 1, 2012

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • change from baseline in soluble receptor for advanced glycation endproducts (sRAGE) after 12 weeks of aerobic exercise

    12 weeks

Secondary Outcomes (3)

  • anthropometric parameters

    12 weeks

  • biochemical parameters

    12 weeks

  • energy expenditure

    12 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR
Behavioral: Control Group

Exercise

ACTIVE COMPARATOR
Behavioral: Aerobic Exercise Group

Interventions

Aerobic Exercise GroupBEHAVIORAL

12 weeks Aerobic exercise

Exercise
Control GroupBEHAVIORAL

maintaining usual activities

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • stable body weight
  • sedentary lifestyle

You may not qualify if:

  • smoked cigarettes
  • cardiovascular disease
  • chronic kidney
  • chronic liver disease
  • pregnant or breastfeeding
  • any other major illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulji University School of Medicine

Seoul, 139-711, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 2, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

KR(1)