Mitochondria and Metabolic Syndrome in a Southern Califor... | NCT00786721

Studies
Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort

NCT00786721

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Metabolic Syndrome
Type 2 Diabetes Mellitus

Interventions

Diffuse Optical Spectroscopy

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

Nov 2006

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

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, Virginia Kimonis, MD, MRCP, 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

There has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic Syndrome.

Detailed Description

Once the mitochondrial defect(s) of these subjects has been defined, the data will be used to develop two non-invasive screening tools to detect mitochondrial defects in Diabetes Mellitus and Metabolic Syndrome patients.

The device call Diffuse Optical Spectroscopy develope at Beckman Laser Instituteis is non-invasive measurement technique, to measure the properties of the muscle tisuue and vascular activity (calf, bicep, or the brain)to evaluate the patient's metabolic status and and to assess muscle mitochondrial OXPHOS function.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diffuse Optical Spectroscopy		muscle properties scanning	Device: Diffuse Optical Spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diffuse Optical Spectroscopy	Device	muscle properties scanning	Diffuse Optical Spectroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Near Infrared Spectroscopy to assess muscle mitochondrial OXPHOS function.		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese descent and have been clinically diagnosed with diabetes mellitus (DM) or have met the study criteria for metabolic syndrome (MS).

Exclusion Criteria:

non chiness descent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

primary care clinic, community sample, residents in a Southern California Chinese Cohort

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce J Tromberg, PhD	Beckman Laser Institute University of California Irvine	Principal Investigator
Douglas c Wallace, PhD	UCI, Molecular and Mitochondrial medicine and Genetics	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided