Genetic Association of Diabetic Retinopathy-1

NCT01298245 | Unknown

• 2 other identifiers: 201008023GBCI-99-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes; Diabetic Retinopathy

Keywords

diabetes; diabetic retinopathy; Chinese; gene; associations

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• the frequencies of haplotypes of different single nucleotide polymorphisms

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with DM who have received ophthalmic fundus examination within 6 months before the study, either with or without diabetic retinopathy

You may qualify if:

• 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.

You may not qualify if:

• Women in pregnancy.
• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Yen Tjing Ling Medical Foundation: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The participants will receive fasting blood sampling 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. Early morning urine samples will also be collected for evaluation of overt proteinuria by a dipstick method.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Chii-Min Hwu, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chii-Min Hwu, MD

CONTACT

886228757516; chhwu@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 17, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

TW (1)