Gene Polymorphism Associated With Macroangiopathy in Type 2 Diabetes Patients

NCT02882945 | Completed DMC

• 1 other identifier: HarbinMU_WHW_001
• Study Type: observational
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Angiopathies

Outcome Measures

Primary Outcomes (1)

• Test of allelic frequencies

  A commercially available kit was used for extraction of genomic DNA from the whole blood samples (PEL-FREEZ Inc., USA). Thirty-two pairs of sequence-specific primers (SSP) for HLA-DRB1\*04 alleles were purchased from One Lambda, Inc. (USA), and the Taq enzyme was purchased from Promega Corp. (USA). The PCR-SSP technique was employed to determine the HLA-DRB1\*04 alleles for each subject. Genes were amplified using the 5700 PCR thermal cycler manufactured by Applied Biosystems Inc. (USA).

  At recruitment

Secondary Outcomes (1)

• Evaluation of serum CRP(C-reactive protein) levels

  At recruitment

Study Arms (3)

Group A

150 healthy blood donors without a family history of diabetes mellitus

Other: Group A

Group B

200 cases of type 2 DM without complications (group B), there were 62 males and 108 females, aged 29-53, with an average age of 42 ± 9 years

Other: Group B

Group C

120 cases of type 2 DM with macroangiopathy complication (group C), there were 70 males and 50 females, aged 40-53, with an average age of 47 ± 6 years. 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

Other: Group C

Interventions

Group A OTHER

150 healthy blood donors without a family history of diabetes mellitus were enrolled in the study.

Also known as: healthy blood donors

Group A

Group B OTHER

200 cases of type 2 DM without complications were enrolled in the study.

Also known as: type 2 DM without complications

Group B

Group C OTHER

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.

Also known as: type 2 DM with macroangiopathy complication

Group C

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

150 healthy blood donors without a family history of diabetes mellitus at the Harbin Blood Disease Research Center were enrolled in the study, and 320 outpatients and hospitalized patients of type 2 diabetes mellitus from the First and Second Affiliated Hospital of Harbin Medical University.

You may qualify if:

• clinical CHD (such as angina pectoris, myocardial infarction) diagnosed by dynamic electrocardiogram and ultrasonic cardiogram;
• coronary atherosclerosis confirmed by coronary angiographic examination;
• cerebral infarction diagnosed by cerebral CT;
• common carotid artery intimal-media thickness (IMT) ≥1.2 mm measured by Doppler ultrasonic examination;
• extensive irregular stenosis of a lower extremity artery (diameter \< 3mm) or segmentally obstructed.

You may not qualify if:

• age \< 20 years
• age \> 60 years

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Laboratory analysis Blood samples were collected after over-night fasting, and serum was stored at -20°C.

MeSH Terms

Conditions

Diabetic Angiopathies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Nan Ma, Master

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 30, 2016

Record last verified: 2016-08