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

Diabetes Mellitus Clinical Trial

Official title:

Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793481
• Other study ID #: 20086415
• Status: Completed
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome

Intervention

Device:
• Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical clinic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Microvascular	Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature	4 weeks