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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Diffuse Optical Spectroscopy

• Registration Number: NCT00793481
• Lead Sponsor: University of California, Irvine

Brief 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.

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..

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-19
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic tool	Diffuse Optical Spectroscopy	Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Primary Outcome Measures

Name	Time	Method
Changes in Microvascular	4 weeks	Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Trial Locations

Locations (1)

Beckman Laser Institute Medical clinic; 🇺🇸 Irvine, California, United States