Effects of Lifestyle Modification on Metabolic Parameters... | NCT01051089

Studies
Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients

NCT01051089

Sponsor

Inha University Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Lifestyle modification

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jan 15, 2010

First Submission Date that Met QC Criteria

Jan 15, 2010

First Posted Date

Jan 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2010

Last Update Posted Date

Jan 18, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle modification	Experimental	supervised exercise with diet education	Behavioral: Lifestyle modification
Control	No Intervention	Control (ordinary care with usual education)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle modification	Behavioral	Exercise and diet education	Lifestyle modification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c, serum adipokine levels		3 months

Secondary Outcomes

Measure	Description	Time Frame
Body composition		3 months
Pulse wave velocity		3 months
Insulin secretion and sensitivity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inha University Hospital	Recruiting	Incheon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided