Diabetes MellitusNCT00793481
Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy
An observational study of Diabetes Mellitus, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, community sample
Who may be able to join
- Adult ages of 45 to 75
- Have been clinically diagnosed with Type II Diabetes Mellitus
- Have a diagnosis of Metabolic Syndrome
Who cannot join
- taking light-sensitive drugs for use in photodynamic therapy
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical clinic
Irvine, California, 92612
About this study
Official title: Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.
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.
Read the 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..
- Conditions
- Diabetes Mellitus
- Being tested
- Diffuse Optical Spectroscopy
- Keywords
- Metabolic Syndrome
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic tool | Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature Receives: Device: Diffuse Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Microvascular
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Ping H Wang, M.D., Principal investigator, Joslin Diabetes Center,UCIBruce Tromberg, PhD, Study director, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793481
- Sponsor's protocol ID
- 20086415
- Status last verified
- Oct 2022
- First submitted
- 14 Nov 2008
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.
- ClinicalTrials.gov ID
- NCT00793481
- Acronym / sponsor ID
- 20086415
- Conditions
- Diabetes Mellitus
- Keywords
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Nov 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic tool | – | Device: Diffuse Optical SpectroscopyDiffuse Optical Spectroscopy non-invasively measure changes in the microvasculature |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, community sample
Key inclusion criteria (3 listed)
- Adult ages of 45 to 75
- Have been clinically diagnosed with Type II Diabetes Mellitus
- Have a diagnosis of Metabolic Syndrome
Key exclusion criteria (2 listed)
- taking light-sensitive drugs for use in photodynamic therapy
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse Optical SpectroscopyDiffuse Optical Spectroscopy non-invasively measure changes in the microvasculature | Device | Diagnostic tool |
Primary outcome
Changes in Microvascular
Time frame: 4 weeks
Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping H Wang, M.D. principal investigator
Joslin Diabetes Center,UCI
Bruce Tromberg, PhD study director
Beckman Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Microvascular (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.