Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort

This study is enrolling participants by invitation only.

First Received: November 4, 2008 Last Updated: March 13, 2009 History of Changes

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute University of California Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00786721

Purpose

There has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic Syndrome.

Condition
Metabolic Syndrome Type 2 Diabetes Mellitus

Genetics Home Reference related topics: mitochondrial neurogastrointestinal encephalopathy disease

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Diffuse Optical Spectroscopy Measurement Technique is Helping Develop More Effective Diagnostic Tools and Therapeutic Regimes for Diabetes, Metabolic Syndrome and Other Mitochondrial Diseases Some Time in the Future

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Near Infrared Spectroscopy to assess muscle mitochondrial OXPHOS function. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
muscle weakness Mitochondria and Metabolic Syndrome

Detailed Description:

Once the mitochondrial defect(s) of these subjects has been defined, the data will be used to develop two non-invasive screening tools to detect mitochondrial defects in Diabetes Mellitus and Metabolic Syndrome patients.

The device call Diffuse Optical Spectroscopy develope at Beckman Laser Instituteis is non-invasive measurement technique, to measure the properties of the muscle tisuue and vascular activity (calf, bicep, or the brain)to evaluate the patient's metabolic status and and to assess muscle mitochondrial OXPHOS function.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic, community sample, residents in a Southern California Chinese Cohort

Criteria

Inclusion Criteria:

Chinese descent and have been clinically diagnosed with diabetes mellitus (DM) or have met the study criteria for metabolic syndrome (MS).

Exclusion Criteria:

non chiness descent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786721

Locations

United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute University of California Irvine

Investigators

Principal Investigator:	Bruce J Tromberg, PhD	Beckman Laser Institute University of California Irvine
Principal Investigator:	Douglas c Wallace, PhD	UCI, Molecular and Mitochondrial medicine and Genetics

More Information

No publications provided

Responsible Party:	Beckman Laser Institute ( Bruce J. Tromberg, Ph. D. )
Study ID Numbers:	LAMMP DOS-01192-29, VOLIGHTEN V-45082
Study First Received:	November 4, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00786721 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Mitochondria and Metabolic Syndrome

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Mitochondrial Diseases
Metabolic Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease
Metabolic Diseases
Syndrome

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009