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The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients

Primary Purpose

Impaired Glucose Tolerance, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exercise prescription
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring impaired glucose tolerance, impaired fasting glucose, diabetes, adipokine, adiponectin, RBP-4, adrenomedullin

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age; 30~70
  2. Subjects with IGT and IFG
  3. Subjects with having possibility of exercise stress test
  4. Subjects with having a strong will to this study

Exclusion Criteria:

  1. Age <30 or >70
  2. Cr more than 1.5 mg/dL
  3. AST, ALT levels more than twice as upper normal range
  4. Subjects having past history of coronary artery disease

Sites / Locations

  • Mi Young LeeRecruiting

Outcomes

Primary Outcome Measures

Improvements of adipokine levels

Secondary Outcome Measures

Prevention of diabetes

Full Information

First Posted
May 10, 2007
Last Updated
May 10, 2007
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00472342
Brief Title
The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients
Official Title
The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many adipokines are thought that related with metabolic disturbance such as glucose intolerance, dyslipidemia, and insulin resistance. It is reported that regular physical training could prevent the progression of diabetes from prediabetes and improve the insulin resistance. After physical training, many adipokine levels were changed due to improving insulin resistance. In this study, we will examine the various adipokine levels such as adiponectin, RBP-4, and adrenomedullin after exercise training through exercise prescription in IFG and IGT patients.
Detailed Description
Backgrounds: Type 2 diabetes mellitus can be caused by genetic and environmental factors. Type 2 diabetes could be prevented by modifying the environmental risk factors such as physical inactivity, heavy eating, and obesity. It is reported that regular physical training could prevent the progression of diabetes from prediabetes such as impaired glucose tolerance (IGT) and impaired fasting glucose (IFG). Prediabetes, the term of IGT and IFG, could progress to type 2 diabetes in 30~40 % within 4~5 years. Moreover, cardiovascular and cerebrovascular events are increased in prediabetic patients like as type 2 diabetic patients. Adipose tissue is thought as a endocrine organ that secrets and regulates various hormones known as adipokines including adiponectin, resistin, leptin, visfatin, tumor necrosis factor (TNF)-α, interleukin-6 (IL-6), and retinol-binding protein 4 (RBP 4). Recently, many adipokines are thought that related with metabolic disturbance such as glucose intolerance, dyslipidemia, and insulin resistance. Adiponectin is known as anti-diabetic factor exerting actions on muscle fatty acid oxidation and insulin sensitivity. Plasma adiponectin levels are significantly decreased in obese, type 2 diabetes, and insulin resistant patients and correlated with insulin sensitivity. Also, adiponectin has anti-inflammatory and anti-atherogenic effects. So, adiponectin is representative insulin sensitivity marker and may be a protective factor against development of type diabetes. In previous data, there was discrepancy in effects of exercise on adiponectin levels. Some study showed exercise interventions could not have effects on adiponectin levels. However, other study suggested that physical fitness may increase adiponectin levels in obese insulin resistant adults. RBP-4, secreted by adiocytes, has effects on reducing glucose transporter 4 (GLUT 4) in adipocytes or increasing gluconeogenesis enzyme activity such as PEPCK in the liver. Also, it is known that RBP-4 is elevated in insulin resistant patients such as type 2 diabetes and obesity. After exercise training, RBP-4 levels were decreased in subjects with improvements of insulin resistance. Adrenomedullin (AM), originally isolated in pheochromocytoma, is recently reported as adipokine. AM is highly expressed in adipocyte of high fat diet mice or obese rat model and elevated in type 2 diabetic patients. Also, AM expression on white and brown adipose tissue was increased after adrenergic stimulation. So, it is expected that AM expression will be changed by exercise. In this study, we will examine the various adipokine levels such as adiponectin, RBP-4, and adrenomedullin after exercise training through exercise prescription in IFG and IGT patients. Methods Subjects Subjects having IFG and IGT on the basis of a 75g oral glucose tolerance test (OGTT) according to American Diabetes Association criteria will be studied. Inclusion Criteria Age; 30~70 Subjects with IGT and IFG Subjects with having possibility of exercise stress test Subjects with having a strong will to this study Exclusion Criteria Age <30 or >70 Cr more than 1.5 mg/dL AST, ALT levels more than twice as upper normal range Subjects having past history of coronary artery disease Study design Study design - before and after methods Visit time - baseline, after 3months, after 6months 1st visit- IGT and IFG diagnosis by 75g OGTT fill up the agreement Lab sampling 2nd visit - exercise stress test exercise prescription by physician follow wup lab sampling 3rd visit - follow up lab sampling completing the study Dietary pattern data - FFQ and 3 day dietary recall Baseline - FFQ and 3 day dietary recall 2nd visit - 3 day dietary recall 3rd visit - 3 day dietary recall After 1 year - FFQ Exercise pattern data - International Physical Activity Questionnaire (IPAQ) 1st, 2nd, and 3rd visits- IPAQ 8) We will compare the parameters according to results of IPAQ (by tertile) 9) We will adjust the parameters by dietary pattern 10) Anthropometric measurements Height, weight, BMI, waist circumference, hip circumference 11) Exercise capacity - exercise tolerance test and Vmax O2 12) Biochemical markers Glucose, HbA1C, WBC, AST, ALT, GGT, total cholesterol, triglyceride, HDL cholesterol, insulin, C-peptide 13) Adipokine adiponectine, RBP-4, adrenomedullin 14) Insulin resistance marker HOMA-IR 15) Inflammatory marker C-reactive protein (CRP)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Diabetes
Keywords
impaired glucose tolerance, impaired fasting glucose, diabetes, adipokine, adiponectin, RBP-4, adrenomedullin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
exercise prescription
Primary Outcome Measure Information:
Title
Improvements of adipokine levels
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Prevention of diabetes
Time Frame
1~5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age; 30~70 Subjects with IGT and IFG Subjects with having possibility of exercise stress test Subjects with having a strong will to this study Exclusion Criteria: Age <30 or >70 Cr more than 1.5 mg/dL AST, ALT levels more than twice as upper normal range Subjects having past history of coronary artery disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choon Hee Chung, Prefessor
Phone
82-33-741-0506
Email
cchung@yonsei.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Young Lee, Dr
Organizational Affiliation
Department of Internal Medicine, Yonsei University Wonju College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Choon Hee Chung, professor
Organizational Affiliation
Department of Internal Medicine, Yonsei Univerisity Wonju College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Mi Young Lee
City
Wonju
State/Province
Kangwon-Do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Young Lee, Dr
Phone
82-33-741-0681
Email
domoe46@yonsei.ac.kr

12. IPD Sharing Statement

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The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients

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