NCT02882945

Gene Polymorphism Associated With Macroangiopathy in Type 2 Diabetes Patients

Polymorphism Analysis of HLA-DRB1*04 Alleles in Patients With Type 2 Diabetic Macroangiopathy in Northeast Chinese

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 470 (actual)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To explore the possible implications of HLA-DRB1\*04 alleles in patients with type 2 DM and macroangiopathy

Detailed description

Previous studies examining the molecular etiology of diabetes mellitus in China and abroad have mainly focused on the relationship between HLA and type 1 diabetes mellitus (DM) (1-3). Due to the complexity of type 2 DM heredity, few researchers have studied the correlation between type 2 DM and HLA. In recent years, it has been suggested that the development of coronary heart disease (CHD) in diabetic individuals is not merely a complication of diabetic macroangiopathy. CHD and diabetic macroangiopathy share some genetic associations. Previous studies have demonstrated that certain HLA\*DRB1\*04 subtypes are associated with an increased risk of cardiovascular disease. Experimental methods: For genomic DNA extraction, 3-5ml venous blood samples were collected from all patients. Coagulation was prevented using EDTA. The procedure for PCR amplification was as follows: denaturing for 100s at 96°C, annealing for 60s at 63°C, 1 cycle; denaturing for 10s at 96°C, annealing for 60s at 63°C, 9 cycles; denaturing for 10 s at 96°C, annealing for 30 s at 59°C; extending for 30 s at 72°C, 20 cycles; maintaining at 4°C. Analyzing PCR products stained by Ethidium Bromide on 2.5% agarose gel electrophoresis. Bands were observed using an ultraviolet light and a biological imaging system. Statistical method: The degree of agreement with Hardy-Weinberg equilibrium was determined using the χ2 test. A t-test was employed for comparison of CRP levels (M ± s) and a χ2 test was performed to compare allelic frequencies. The relative risk rate (RR) was calculated as (Number of patients with the gene×Number of people in control group without the gene) divided by (Number of people in control group with the gene×Number of the patients without the gene). PC was calculated using Fisher's method if χ2 \> 3.84.

Conditions

• Diabetic Angiopathies

Interventions

Type	Name	Description
OTHER	Group A	150 healthy blood donors without a family history of diabetes mellitus were enrolled in the study.
OTHER	Group B	200 cases of type 2 DM without complications were enrolled in the study.
OTHER	Group C	120 cases of type 2 DM with macroangiopathy complication were enrolled in the study.. Among the group C subjects, 65 individuals had CHD; 55 patients had cerebrovascular disease (CVD); and 30 subjects had a combination of peripheral vascular diseases (PVD) and CHD.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2016-08-30
• Last updated: 2016-08-30