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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00793481
First received: November 14, 2008
Last updated: August 5, 2015
Last verified: August 2015

November 14, 2008
August 5, 2015
November 2008
November 2013   (final data collection date for primary outcome measure)
Changes in Microvascular [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
To monitor microvascular changes in patients with Metabolic Syndrome and with DM to assess their disease progression and cardiovascular risks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00793481 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.
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.
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..
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
primary care clinic, community sample
Diabetes Mellitus
Device: Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
Diagnostic tool
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
Intervention: Device: Diffuse Optical Spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793481
NIH-LAMMP-2008-6415
No
Not Provided
Not Provided
Beckman Laser Institute and Medical Center, University of California, Irvine
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
University of California, Irvine
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP