Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472342
Status:
UNKNOWN
Last Update Posted:
2007-05-11
First Post:
2007-05-10
Brief Title:
The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
The Effects of Exercise on Adipokine in Impaired Fasting Glucose or Impaired Glucose Tolerance Patients
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 3040 within 45 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
1 Age 3070
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 15 mgdL
3 AST ALT levels more than twice as upper normal range
4 Subjects having past history of coronary artery disease
Study design
1 Study design - before and after methods
2 Visit time - baseline after 3months after 6months
3 1st visit- IGT and IFG diagnosis by 75g OGTT fill up the agreement Lab sampling
4 2nd visit - exercise stress test exercise prescription by physician follow wup lab sampling
5 3rd visit - follow up lab sampling completing the study
6 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
7 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
Prediabetes the term of IGT and IFG could progress to type 2 diabetes in 3040 within 45 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
1 Age 3070
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 15 mgdL
3 AST ALT levels more than twice as upper normal range
4 Subjects having past history of coronary artery disease
Study design
1 Study design - before and after methods
2 Visit time - baseline after 3months after 6months
3 1st visit- IGT and IFG diagnosis by 75g OGTT fill up the agreement Lab sampling
4 2nd visit - exercise stress test exercise prescription by physician follow wup lab sampling
5 3rd visit - follow up lab sampling completing the study
6 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
7 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None