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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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: November 2008
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Diffuse Optical Spectroscopy
    MUSCLE PROPERTIES
Detailed Description:

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..

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793481

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Joslin Diabetes Center
Volighten Scientific, Ltd.
Investigators
Principal Investigator: Ping H Wang, M.D. Joslin Diabetes Center,UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00793481     History of Changes
Other Study ID Numbers: LAMMP-DOS-RR01192-29
Study First Received: November 14, 2008
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Metabolic Syndrome

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

ClinicalTrials.gov processed this record on May 21, 2013