Diabetic AngiopathiesNCT02882945
Gene Polymorphism Associated With Macroangiopathy in Type 2 Diabetes Patients
An observational study of Diabetic Angiopathies, run by First Affiliated Hospital of Harbin Medical University.
Trial summary
To explore the possible implications of HLA-DRB1*04 alleles in patients with type 2 DM and macroangiopathy Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Angiopathies
- What is being tested?
- Group A, Group B and Group C
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Sep 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- age < 20 years
- age > 60 years
About this study
Official title: Polymorphism Analysis of HLA-DRB1*04 Alleles in Patients With Type 2 Diabetic Macroangiopathy in Northeast Chinese
To explore the possible implications of HLA-DRB1*04 alleles in patients with type 2 DM and macroangiopathy
Read the 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
- Being tested
- Group A, Group B, Group C
- Medical subject headings
- Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called healthy blood donors
150 healthy blood donors without a family history of diabetes mellitus were enrolled in the study.
Group BOther
Also called type 2 DM without complications
200 cases of type 2 DM without complications were enrolled in the study.
Group COther
Also called type 2 DM with macroangiopathy complication
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 150 healthy blood donors without a family history of diabetes mellitus Receives: 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 Receives: 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 Receives: Other: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At recruitment
Secondary outcomes (1)
Evaluation of serum CRP(C-reactive protein) levels
A commercially available 96-well plate ELISA assay kit (introassay CV 1.7%~3.9%, interassay CV 2.8%~5.1%) was used to quantify hs-CRP in serum (DSL Inc., USA). All samples were evaluated in duplicate. The absorbance (OD) was determined using a BIO-RAD2550 microwell plate reader (USA).
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic AngiopathiesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Wu, First Affiliated Hospital of Harbin Medical University
- Investigators
- Nan Ma, Master, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882945
- Sponsor's protocol ID
- HarbinMU_WHW_001
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism Analysis of HLA-DRB1*04 Alleles in Patients With Type 2 Diabetic Macroangiopathy in Northeast Chinese
- ClinicalTrials.gov ID
- NCT02882945
- Acronym / sponsor ID
- HarbinMU_WHW_001
- Conditions
- Diabetic Angiopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Aug 2016 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Group A150 healthy blood donors without a family history of diabetes mellitus |
| Group B | – | Other: Group B200 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 |
| Group C | – | Other: Group C120 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- age < 20 years
- age > 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: healthy blood donors150 healthy blood donors without a family history of diabetes mellitus were enrolled in the study. | Other | Group A |
| Group BAlso: type 2 DM without complications200 cases of type 2 DM without complications were enrolled in the study. | Other | Group B |
| Group CAlso: type 2 DM with macroangiopathy complication120 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. | Other | Group C |
Primary outcome
Test of allelic frequencies
Time frame: At recruitment
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).
1 secondary outcome
Evaluation of serum CRP(C-reactive protein) levels
Time frame: At recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Nan Ma, Master principal investigator
First Affiliated Hospital of Harbin Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Angiopathies, run by First Affiliated Hospital of Harbin Medical University.
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 2 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: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of allelic frequencies (time frame: At recruitment). 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 30 Aug 2016.