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Multi-faceted Evaluations Following Weight Reduction in Subjects With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065753
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : February 9, 2010
Information provided by:
Taichung Veterans General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Lifestyle Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Wight Reduction by Life-style Modification
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. change of body weight [ Time Frame: 12-16 weeks ]

Secondary Outcome Measures :
  1. Change of Rho kinase [ Time Frame: 12-16 weeks ]
  2. Change of central aortic blood pressure and related hemodynamics [ Time Frame: 12-16 weeks ]
  3. Change of Brain-derived neurotrophic factor [ Time Frame: 12-16 weeks ]
  4. Change of MRI images of cardiac function [ Time Frame: 12-16 weeks ]
  5. Change of profiles before and after OGTT [ Time Frame: 12-16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 20 and 65 years
  • Metabolic syndrome by IDF 2005 criteria

Exclusion Criteria:

  • known diabetes
  • obesity due to endocrinologic disorders
  • Psychological disorder or using psychological medications
  • Abnormal liver function (three-fold upper normal limit)
  • Abnormal renal function (1.5-fold upper normal limit)
  • Investigator judgement for abnormal clinical data
  • Life-threatening disease
  • Acute infective status
  • Alcohol or drug abuse
  • pregnant potency without prevention
  • receiving other clinical trial in recently three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065753

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Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
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Principal Investigator: Wayne HH Sheu, MD, PhD Taichung Veterans General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Wayne Huey-Herng Sheu, Taichung Veterans General Hospital Identifier: NCT01065753    
Other Study ID Numbers: C07220
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: December 2009
Keywords provided by Taichung Veterans General Hospital:
Rho kinase
Brain-derived neurotrophic factor
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases