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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, lifestyle modification

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inha University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle modification

Control

Arm Description

supervised exercise with diet education

Control (ordinary care with usual education)

Outcomes

Primary Outcome Measures

HbA1c, serum adipokine levels

Secondary Outcome Measures

Body composition
Pulse wave velocity
Insulin secretion and sensitivity
VO2max

Full Information

First Posted
January 15, 2010
Last Updated
January 15, 2010
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01051089
Brief Title
Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
Official Title
Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Inha University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, lifestyle modification

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
supervised exercise with diet education
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control (ordinary care with usual education)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
Exercise and diet education
Primary Outcome Measure Information:
Title
HbA1c, serum adipokine levels
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
3 months
Title
Pulse wave velocity
Time Frame
3 months
Title
Insulin secretion and sensitivity
Time Frame
3 months
Title
VO2max
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moonsuk Nam, MD, PhD
Phone
82-32-890-3689
Email
namms@inha.ac.kr
First Name & Middle Initial & Last Name & Degree
Moonsuk Nam, MD, PhD

12. IPD Sharing Statement

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

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