Type 1 DiabetesNCT00824395
The Genetics of Diabetes in Southern California Chinese Americans
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes, Metabolic Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2006
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are currently recruiting Chinese Americans living in Southern California, espcially in Orange and Los Angeles Counties. We are particularly in need of Chinese American men and women with diabetes as well as healthy male controls. We can arrange for offsite weekend trips to cities within LA or Orange Counties for eligible groups of 10 or more people.
Who may be able to join
- Chinese or Taiwanese ancestry
- Resident of Southern California
- Age between 40 and 65
- Both people with and without diabetes are welcome to enroll.
Who cannot join
- Younger than 40 years or older than 65 years
- Ancestry is not Chinese or Taiwanese
- Not a resident of Southern California
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Irvine General Clinical Research Center
Irvine, California, 92697
About this study
Official title: Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort
The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.
Read the detailed description
Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM \& MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM \& MS.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Metabolic Syndrome
- Keywords
- diabetes, type 1, type 2, metabolic syndrome, mitochondria
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals with diabetes | |
| 2 | Individuals without diabetes |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2006
- Primary completionJan 2006
- Study completionJan 2006
Why it stopped: Non applicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Douglas C Wallace, PhD, Principal investigator, UC Irvine Center for Mitochondrial Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824395
- Sponsor's protocol ID
- 2005-4675
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2009
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort
- ClinicalTrials.gov ID
- NCT00824395
- Acronym / sponsor ID
- 2005-4675
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Metabolic Syndrome
- Keywords
- diabetes, type 1, type 2, metabolic syndrome, mitochondria
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Non applicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Jan 2006
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Jan 2009 (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 purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.
Detailed description
Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM \& MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM \& MS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Individuals with diabetes |
| 2 | – | –Individuals without diabetes |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are currently recruiting Chinese Americans living in Southern California, espcially in Orange and Los Angeles Counties. We are particularly in need of Chinese American men and women with diabetes as well as healthy male controls. We can arrange for offsite weekend trips to cities within LA or Orange Counties for eligible groups of 10 or more people.
Key inclusion criteria (4 listed)
- Chinese or Taiwanese ancestry
- Resident of Southern California
- Age between 40 and 65
- Both people with and without diabetes are welcome to enroll.
Key exclusion criteria (3 listed)
- Younger than 40 years or older than 65 years
- Ancestry is not Chinese or Taiwanese
- Not a resident of Southern California
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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.
Douglas C Wallace, PhD principal investigator
UC Irvine Center for Mitochondrial Medicine
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 Type 1 Diabetes and Type 2 Diabetes, 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 25 Jan 2021.