DiabetesDMR-1NCT01298245
Genetic Association of Diabetic Retinopathy-1
An observational study of Diabetes and Diabetic Retinopathy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The primary purpose of the study is to investigate allele frequencies of candidate genes in Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus examination (either by an ophthalmoscope or fundus… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes, Diabetic Retinopathy
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Dec 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with DM who have received ophthalmic fundus examination within 6 months before the study, either with or without diabetic retinopathy
Who may be able to join
- Patients with DM, diagnosed by the 2010 American Diabetes Association diagnosis criteria.
- Men or women.
- Aged 20 ~ 75 years old (inclusive).
- Who have received ophthalmic fundus examination within 6 months before the study: either (1)by an ophthalmoscope or fundus camera (results reviewed by a qualified physician), or (2)the ophthalmoscopic examination being performed by an ophthalmologist.
- Willing to participate in the study by signing an informed consent.
Who cannot join
- Women in pregnancy.
- No document to verify the results of the ophthalmic fundus examination requiring for the inclusion.
- History of mental incapacity or language barriers that may preclude adequate understanding or cooperation in the study.
- Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Chii-Min Hwu, MD, 8862287516, chhwu@vghtpe.gov.tw
About this study
Official title: Genetic Association Studies of Diabetic Retinopathy (1): Vanguard Phase
The primary purpose of the study is to investigate allele frequencies of candidate genes in Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus examination (either by an ophthalmoscope or fundus camera) within 6 months before the study will be recruited for the study. Each subject will receive anthropometric and blood pressure measurements. Then, fasting blood samples will be taken for the measurements of glucose, HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for DNA extraction from buffy coat. Meanwhile, the participant will receive structural questionnaires for demography, personal history, medical history and concomitant medication. Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions will be genotyped by using the ABI TaqMan assays. The differences in the distribution of genotypes and alleles between the study groups will be analyzed using appropriate statistical methods. Through the study, the investigators hope to build up a platform for future large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up priority of candidate loci for future studies.
Read the detailed description
Diabetic retinopathy (DR) is one of the most frequent microvascular complications of diabetes (DM). Current guidelines recommend that patients with DM should receive ophthalmic fundus examination annually. DR poses a serious threat to the health of millions patients who have DM. Nowadays, DR has become the leading cause of new cases of visual impairment and blindness among adults.
Genetic factors are likely to account for the susceptibility to DR for the differences in DR incidence between individuals with diabetes. Familial aggregation studies showed that increased risk of severe DR was noted among family members with diabetes with moderate heritability of DR risk. Racial and ethnic differences in the prevalence of DR may also explain some parts of influence of genetic or environmental/cultural risk factors. There were over 30 candidate genes involved in metabolic mechanisms and functional pathways associated with DR. However, consistent associations between candidate genes and DR have yet been identified. The current study is designed to build up a working platform for future large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up priority of candidate loci for future researches.
In the present study, the investigators plan to recruit 200 Chinese patients with DM who have received ophthalmic fundus examination (either by an ophthalmoscope or fundus camera) within 6 months before the study. Each subject will receive anthropometric and blood pressure measurements. Then, fasting blood samples will be taken for the measurements of glucose, HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for DNA extraction from buffy coat. Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions will be genotyped by using the ABI TaqMan assays. The differences in the distribution of genotypes and alleles between the study groups will be analyzed using appropriate statistical methods.
- Conditions
- Diabetes, Diabetic Retinopathy
- Keywords
- diabetes, diabetic retinopathy, Chinese, gene, associations
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
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 |
|---|---|---|
| Case: diabetic retinopathy | Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study and those with known positive results of diabetic retinopathy | |
| Control: no diabetic retinopathy | Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study and those without known positive results of diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in the distribution of candidate genotypes and alleles between the study groups
Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study. The eligible participants will be grouped by the results of prior fundus examination: those with known history of diabetic retinopathy; those without known history of diabetic retinopathy.
Measured: 12 months
Secondary outcomes (1)
the frequencies of haplotypes of different single nucleotide polymorphisms
We will estimate the frequencies of haplotypes of different single nucleotide polymorphisms, calculate linkage disequilibrium between single nucleotide polymorphisms, and conduct haplotype analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Yen Tjing Ling Medical Foundation
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chii-Min Hwu, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298245
- Sponsor's protocol ID
- 201008023GB
- Other IDs
- CI-99-1
- Acronym
- DMR-1
- Status last verified
- Dec 2011
- First submitted
- 15 Feb 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Association Studies of Diabetic Retinopathy (1): Vanguard Phase
- ClinicalTrials.gov ID
- NCT01298245
- Acronym / sponsor ID
- DMR-1 / 201008023GB
- Conditions
- Diabetes, Diabetic Retinopathy
- Keywords
- diabetes, diabetic retinopathy, Chinese, gene, associations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Yen Tjing Ling Medical Foundation
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Feb 2011 (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 primary purpose of the study is to investigate allele frequencies of candidate genes in Chinese diabetic patients with or without known diabetic retinopathy. Two hundred Chinese diabetic patients, aged between 20 - 75 years old, who have received ophthalmic fundus examination (either by an ophthalmoscope or fundus camera) within 6 months before the study will be recruited for the study. Each subject will receive anthropometric and blood pressure measurements. Then, fasting blood samples will be taken for the measurements of glucose, HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for DNA extraction from buffy coat. Meanwhile, the participant will receive structural questionnaires for demography, personal history, medical history and concomitant medication. Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions will be genotyped by using the ABI TaqMan assays. The differences in the distribution of genotypes and alleles between the study groups will be analyzed using appropriate statistical methods. Through the study, the investigators hope to build up a platform for future large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up priority of candidate loci for future studies.
Detailed description
Diabetic retinopathy (DR) is one of the most frequent microvascular complications of diabetes (DM). Current guidelines recommend that patients with DM should receive ophthalmic fundus examination annually. DR poses a serious threat to the health of millions patients who have DM. Nowadays, DR has become the leading cause of new cases of visual impairment and blindness among adults.
Genetic factors are likely to account for the susceptibility to DR for the differences in DR incidence between individuals with diabetes. Familial aggregation studies showed that increased risk of severe DR was noted among family members with diabetes with moderate heritability of DR risk. Racial and ethnic differences in the prevalence of DR may also explain some parts of influence of genetic or environmental/cultural risk factors. There were over 30 candidate genes involved in metabolic mechanisms and functional pathways associated with DR. However, consistent associations between candidate genes and DR have yet been identified. The current study is designed to build up a working platform for future large-scale genetic studies of diabetic retinopathy. The investigators also hope to set up priority of candidate loci for future researches.
In the present study, the investigators plan to recruit 200 Chinese patients with DM who have received ophthalmic fundus examination (either by an ophthalmoscope or fundus camera) within 6 months before the study. Each subject will receive anthropometric and blood pressure measurements. Then, fasting blood samples will be taken for the measurements of glucose, HbA1c, lipid profile, and biochemistry. An additional 10 ml blood sample will be taken for DNA extraction from buffy coat. Single nucleotide polymorphisms (SNPs) in candidate genes and in targeted chromosome regions will be genotyped by using the ABI TaqMan assays. The differences in the distribution of genotypes and alleles between the study groups will be analyzed using appropriate statistical methods.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: diabetic retinopathy | – | –Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study and those with known positive results of diabetic retinopathy |
| Control: no diabetic retinopathy | – | –Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study and those without known positive results of diabetic retinopathy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DM who have received ophthalmic fundus examination within 6 months before the study, either with or without diabetic retinopathy
Key inclusion criteria (5 listed)
- Patients with DM, diagnosed by the 2010 American Diabetes Association diagnosis criteria.
- Men or women.
- Aged 20 ~ 75 years old (inclusive).
- Who have received ophthalmic fundus examination within 6 months before the study: either (1)by an ophthalmoscope or fundus camera (results reviewed by a qualified physician), or (2)the ophthalmoscopic examination being performed by an ophthalmologist.
- Willing to participate in the study by signing an informed consent.
Key exclusion criteria (4 listed)
- Women in pregnancy.
- No document to verify the results of the ophthalmic fundus examination requiring for the inclusion.
- History of mental incapacity or language barriers that may preclude adequate understanding or cooperation in the study.
- Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
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
The differences in the distribution of candidate genotypes and alleles between the study groups
Time frame: 12 months
Patients with diabetes who have received ophthalmic fundus examination within 6 months before the study. The eligible participants will be grouped by the results of prior fundus examination: those with known history of diabetic retinopathy; those without known history of diabetic retinopathy.
1 secondary outcome
the frequencies of haplotypes of different single nucleotide polymorphisms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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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.
Chii-Min Hwu, MD principal investigator
Taipei Veterans General Hospital, Taiwan
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 Diabetes and Diabetic Retinopathy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2011. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chii-Min Hwu, MD (886228757516, chhwu@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences in the distribution of candidate genotypes and alleles between the study groups (time frame: 12 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 6 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.