NCT00793481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

November 14, 2008

Last Update Submit

October 28, 2022

Conditions

Diabetes Mellitus

Keywords

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Changes in Microvascular

    Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

    4 weeks

Study Arms (1)

Diagnostic tool

Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Device: Diffuse Optical Spectroscopy

Interventions

Diffuse Optical SpectroscopyDEVICE

Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature

Diagnostic tool

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic, community sample

You may qualify if:

  • Adult ages of 45 to 75
  • Have been clinically diagnosed with Type II Diabetes Mellitus
  • Have a diagnosis of Metabolic Syndrome

You may not qualify if:

  • taking light-sensitive drugs for use in photodynamic therapy
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Diabetes MellitusMetabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Ping H Wang, M.D.

    Joslin Diabetes Center,UCI

    PRINCIPAL INVESTIGATOR

  • Bruce Tromberg, PhD

    Beckman Laser Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ping Wang, M.D., Professor of Medicine

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)