The Use of Diffuse Optical Spectroscopy to Characterize i... | NCT02146885

Studies
The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention

NCT02146885

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Overweight

Interventions

Weight Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2013Actual

Primary Completion Date

Jan 13, 2017Actual

Completion Date

Jan 13, 2017Actual

First Submitted Date

May 19, 2014

First Submission Date that Met QC Criteria

May 20, 2014

First Posted Date

May 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Shaista Malik, M.D., Assistant Professor-Cardiology, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weight Control		Weight Control	Other: Weight Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weight Control	Other	Weight Control	Weight Control

Measure	Description	Time Frame
Weight Control		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body Mass Index greater than 25, overweight
Participation in Weight Loss program

Exclusion Criteria:

A medical history of myocardial infarction or cerebrovascular stroke
Pregnancy or planned pregnancy during the course of the study period

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Study population will be selected from University of California Irvine Medical Center Department of Cardiology, preventive cardiology intervention program.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaista Malik, MD	Beckman Laser Institute, UCI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute		Irvine	California	92612	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided