NCT00786721

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Typical duration 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, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

November 4, 2008

Last Update Submit

October 28, 2022

Conditions

Metabolic SyndromeType 2 Diabetes Mellitus

Keywords

Mitochondria and Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Near Infrared Spectroscopy to assess muscle mitochondrial OXPHOS function.

    4 weeks

Study Arms (1)

Diffuse Optical Spectroscopy

muscle properties scanning

Device: Diffuse Optical Spectroscopy

Interventions

Diffuse Optical SpectroscopyDEVICE

muscle properties scanning

Diffuse Optical Spectroscopy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • non chiness descent

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

Metabolic SyndromeDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Virginia Kimonis, MD, MRCP

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

November 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)