Genetic Association of Diabetic Retinopathy-1 (DMR-1)
Genetic Association Studies of Diabetic Retinopathy (1): Vanguard Phase
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Chii-Min Hwu, MD
- Telefonnummer: 886228757516
- E-post: chhwu@vghtpe.gov.tw
Studieorter
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Taipei, Taiwan, 112
- Rekrytering
- Taipei Veterans General Hospital
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Kontakt:
- Chii-Min Hwu, MD
- Telefonnummer: 8862287516
- E-post: chhwu@vghtpe.gov.tw
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The differences in the distribution of candidate genotypes and alleles between the study groups
Tidsram: 12 months
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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.
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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the frequencies of haplotypes of different single nucleotide polymorphisms
Tidsram: 12 months
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We will estimate the frequencies of haplotypes of different single nucleotide polymorphisms, calculate linkage disequilibrium between single nucleotide polymorphisms, and conduct haplotype analysis.
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12 months
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201008023GB
- CI-99-1 (Annat bidrag/finansieringsnummer: Yen Tjing Ling Medical Foundation)
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