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
  Purpose

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 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:


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

Primary Outcome Measures:
  • Changes in Microvascular [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature


Enrollment: 50
Study Start Date: November 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: 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..

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: November 14, 2008
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Metabolic Syndrome

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

ClinicalTrials.gov processed this record on August 26, 2015