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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Joslin Diabetes Center
Volighten Scientific, Ltd.
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00793481
First received: November 14, 2008
Last updated: December 26, 2012
Last verified: December 2012
History of Changes

November 14, 2008
December 26, 2012
November 2008
November 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00793481 on ClinicalTrials.gov Archive Site
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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.

This is a pilot study to determine whether changes in tissue oxygenation, oxygen metabolism, and indicators of tissue damage can non-invasively be quantified using DOS in patients with Metabolic Syndrome, patients with both Type I DM, Type II DM, and in non-diseased subjects.

The researchers want to use DOS as a means to monitor changes in the microvasculature of patients with Metabolic Syndrome and DM, and patients with DPN, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. This will be done by measuring 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 DOS to tissue hemodynamics provides an impressive arena of useful clinical applications..
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic, community sample
Diabetes Mellitus
Device: Diffuse Optical Spectroscopy
MUSCLE PROPERTIES
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
November 2015
November 2015   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793481
LAMMP-DOS-RR01192-29
No
Montana Compton, University of California, Irvine
Montana Compton
  • Beckman Laser Institute University of California Irvine
  • Joslin Diabetes Center
  • Volighten Scientific, Ltd.
Principal Investigator: Ping H Wang, M.D. Joslin Diabetes Center,UCI
University of California, Irvine
December 2012

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