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Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy

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ClinicalTrials.gov Identifier: NCT00793481
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Metabolic Syndrome is a highly prevalent condition that is comprised of several major clustering factors that increase the risk for developing cardiovascular disease. Diffuse Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties of near-infrared light in tissues such as muscle in order to quantify the absolute concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides quantitative and functional information on the microvasculature related to tissue perfusion, metabolic changes, and indicators of tissue damage.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: Diffuse Optical Spectroscopy

Detailed Description:
The researchers can use Diffuse Optical Spectroscopy to monitor changes in the microvasculature of patients with Metabolic Syndrome and diabetic mellitus, and patients with Diabetic Peripheral and Autonomic Neuropathy, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. The Diffuse Optical Spectroscopy measure the changes in the concentration and oxygen saturation of hemoglobin in the microvasculature under stress, for example, during exercise and in response to changes in breathing habits. The sensitivity of Diffuse Optical Spectroscopy to tissue hemodynamics provides an impressive arena of useful clinical applications..

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.
Study Start Date : November 2008
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Diagnostic tool
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
Device: Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Outcome Measures

Primary Outcome Measures :
  1. Changes in Microvascular [ Time Frame: 4 weeks ]
    Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, community sample

Inclusion Criteria:

  • Adult ages of 45 to 75
  • Have been clinically diagnosed with Type II Diabetes Mellitus
  • Have a diagnosis of Metabolic Syndrome

Exclusion Criteria:

  • taking light-sensitive drugs for use in photodynamic therapy
  • pregnant
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00793481

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
Principal Investigator: Ping H Wang, M.D. Joslin Diabetes Center,UCI
Study Director: Bruce Tromberg, PhD Beckman Laser Institute
More Information

Responsible Party: Beckman Laser Institute and Medical Center, Ping Wang, M.D., Professor of Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00793481     History of Changes
Other Study ID Numbers: NIH-LAMMP-2008-6415
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Metabolic Syndrome

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance