Multi-faceted Evaluations Following Weight Reduction in Subjects With Metabolic Syndrome
Central obesity, core of metabolic syndrome, has been recognized as one of the rooting factors for development of diabetes and cardiovascular disease. Although efforts have been devoted to the studies of central obesity and/or metabolic syndrome, much remained unknown as to how obesity influences cellular as well as cardiac functions, what is the central regulation of one's body weight.
Weight loss is an undisputed way to improve cardiovascular and metabolic disorders in obese individuals. Previous studies have demonstrated that weight loss by 5% of initial weight universally provide substantial benefits in these subjects. However, there are little integrated research teams, composed of different disciplines, share common weight reduction program to look at different aspects of weight reduction in non-diabetic individuals with metabolic syndrome. The significances of this proposal we plan to target, namely Rho kinase activity from peripheral leukocyte, several cardiac functions measured by noninvasive technique (VP-2000) and MRI, circulating brain-derived neurotrophic factors (BDNF) levels, are fully explained detailed in each sub-proposal.
In order to accomplish this integrated proposal, we will form research teams including endocrinologists, cardiologists, radiologists, and a coordinating data center. We pan to recruit 40 non-diabetic individuals with metabolic syndrome to participate this 12-16 weeks weight reduction program. Twenty-five age, sex matched non-diabetes lean will be served as controls. Oral glucose tolerance test, fasting blood obtained, noninvasive vascular and MRI examinations will be applied before and after weight reduction program in those achieving at least 5% loss of initial weight.
In summary, this study will investigate the effects of weight loss on (1) Rho kinase activity obtained from peripheral leukocyte; (2). Aortic stiffness, central aortic pressure and hemodynamic by a noninvasive vascular profiling system (VP-2000); (3) Brain function specifically reflecting by circulating BDNF; (4). Aortic elastic properties and left ventricular function by using MRI examinations, in non-diabetic individuals of metabolic syndrome.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Wight Reduction by Life-style Modification|
- change of body weight [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
- Change of Rho kinase [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
- Change of central aortic blood pressure and related hemodynamics [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
- Change of Brain-derived neurotrophic factor [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
- Change of MRI images of cardiac function [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
- Change of profiles before and after OGTT [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Life-style modification
Life-style modification for 40 study subjects with metabolic syndrome in comparison to 25 non-obesity subjects for control.
Behavioral: Lifestyle Counseling
Diet control with exercise
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065753
|Taichung Veterans General Hospital|
|Taichung, Taiwan, 407|
|Principal Investigator:||Wayne HH Sheu, MD, PhD||Taichung Veterans General Hospital|