OverweightNCT02146885
The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention
An observational study of Overweight, run by University of California, Irvine at 1 site in United States.
Trial summary
The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2013to 13 Jan 2017
- How long will I take part?
- 3 Months
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from University of California Irvine Medical Center Department of Cardiology, preventive cardiology intervention program.
Who may be able to join
- Body Mass Index greater than 25, overweight
- Participation in Weight Loss program
Who cannot join
- A medical history of myocardial infarction or cerebrovascular stroke
- Pregnancy or planned pregnancy during the course of the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Diffuse Optical Spectroscopy to Characterize Adipose Tissue Oxygenation and Vascular Reactivity in Response to Weight-Loss Intervention
The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.
Read the detailed description
Optical technologies under development at the Beckman Laser Institute.
Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. The researcher use Diffuse Optical Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.
- Conditions
- Overweight
- Being tested
- Weight Control
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight ControlOther
Weight Control
| Study group | Role | What they receive |
|---|---|---|
| Weight Control | Weight Control Receives: Other: Weight Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study start8 Jan 2013
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 21 participants (actual)
- Target duration
- 3 Months
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
- Shaista Malik, MD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146885
- Sponsor's protocol ID
- 20129158
- Status last verified
- Oct 2022
- First submitted
- 19 May 2014
- 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
- The Use of Diffuse Optical Spectroscopy to Characterize Adipose Tissue Oxygenation and Vascular Reactivity in Response to Weight-Loss Intervention
- ClinicalTrials.gov ID
- NCT02146885
- Acronym / sponsor ID
- 20129158
- Conditions
- Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 26 May 2014 (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.
The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.
Detailed description
Optical technologies under development at the Beckman Laser Institute.
Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. The researcher use Diffuse Optical Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Control | – | Other: Weight ControlWeight Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from University of California Irvine Medical Center Department of Cardiology, preventive cardiology intervention program.
Key inclusion criteria (2 listed)
- Body Mass Index greater than 25, overweight
- Participation in Weight Loss program
Key exclusion criteria (2 listed)
- A medical history of myocardial infarction or cerebrovascular stroke
- Pregnancy or planned pregnancy during the course of the study period
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 |
|---|---|---|
| Weight ControlWeight Control | Other | Weight Control |
Primary outcome
Weight Control
Time frame: 3 months
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.
Shaista Malik, MD principal investigator
Beckman Laser Institute, UCI
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 Overweight, 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 2 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?
Weight Control (time frame: 3 months). 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; AzTrials last refreshed its copy on 1 Nov 2026.