NCT01051089

Brief Summary

The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

January 15, 2010

Last Update Submit

January 15, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellituslifestyle modification

Outcome Measures

Primary Outcomes (1)

  • HbA1c, serum adipokine levels

    3 months

Secondary Outcomes (4)

  • Body composition

    3 months

  • Pulse wave velocity

    3 months

  • Insulin secretion and sensitivity

    3 months

  • VO2max

    3 months

Study Arms (2)

Lifestyle modification

EXPERIMENTAL

supervised exercise with diet education

Behavioral: Lifestyle modification

Control

NO INTERVENTION

Control (ordinary care with usual education)

Interventions

Lifestyle modificationBEHAVIORAL

Exercise and diet education

Lifestyle modification

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 25 or older,
  • type 2 diabetes mellitus,
  • HbA1c 6.5-10% BMI 23 or higher.

You may not qualify if:

  • type 1 diabetes,
  • recent (within 3 months) cardiovascular event,
  • severe hepatic or renal dysfunction,
  • insulin use,
  • glucocorticoid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

January 15, 2010

First Posted

January 18, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

KR(1)