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

NCT01065753 | Completed

• 1 other identifier: C07220
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Rho kinase; Brain-derived neurotrophic factor

Outcome Measures

Primary Outcomes (1)

• change of body weight

  12-16 weeks

Secondary Outcomes (5)

• Change of Rho kinase

  12-16 weeks

• Change of central aortic blood pressure and related hemodynamics

  12-16 weeks

• Change of Brain-derived neurotrophic factor

  12-16 weeks

• Change of MRI images of cardiac function

  12-16 weeks

• Change of profiles before and after OGTT

  12-16 weeks

Study Arms (1)

Life-style modification

EXPERIMENTAL

Life-style modification for 40 study subjects with metabolic syndrome in comparison to 25 non-obesity subjects for control.

Behavioral: Lifestyle Counseling

Interventions

Lifestyle Counseling BEHAVIORAL

Diet control with exercise

Life-style modification

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Related Publications (3)

• Liang KW, Tsai IC, Lee WJ, Lin SY, Lee WL, Lee IT, Fu CP, Wang JS, Sheu WH. Correlation between reduction of superior interventricular groove epicardial fat thickness and improvement of insulin resistance after weight loss in obese men. Diabetol Metab Syndr. 2014 Oct 29;6(1):115. doi: 10.1186/1758-5996-6-115. eCollection 2014.

  PMID: 25383099 DERIVED

• Lee IT, Fu CP, Lee WJ, Liang KW, Lin SY, Wan CJ, Sheu WH. Brain-derived neurotrophic factor, but not body weight, correlated with a reduction in depression scale scores in men with metabolic syndrome: a prospective weight-reduction study. Diabetol Metab Syndr. 2014 Feb 13;6(1):18. doi: 10.1186/1758-5996-6-18.

  PMID: 24524285 DERIVED

• Lee IT, Lee WJ, Tsai IC, Liang KW, Lin SY, Wan CJ, Fu CP, Sheu WH. Brain-derived neurotrophic factor not associated with metabolic syndrome but inversely correlated with vascular cell adhesion molecule-1 in men without diabetes. Clin Chim Acta. 2012 May 18;413(9-10):944-8. doi: 10.1016/j.cca.2012.02.013. Epub 2012 Feb 21.

  PMID: 22374129 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Wayne HH Sheu, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 9, 2010

Record last verified: 2009-12

Locations

TW (1)