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

This study has been completed.
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01065753
First received: February 8, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention
Metabolic Syndrome
Behavioral: Lifestyle Counseling

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • change of body weight [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065753

Locations
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Wayne HH Sheu, MD, PhD Taichung Veterans General Hospital
  More Information

No publications provided by Taichung Veterans General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wayne Huey-Herng Sheu, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01065753     History of Changes
Other Study ID Numbers: C07220
Study First Received: February 8, 2010
Last Updated: February 8, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
Rho kinase
Brain-derived neurotrophic factor

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014