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NCT04424706 Clinical Trial

The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis

Type 2 Diabetes Clinical Trial

Official title:
The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis in Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04424706
Other study ID # KY20200320-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date December 30, 2020

Study information
Verified date June 2020
Source Nanjing First Hospital, Nanjing Medical University
Contact Jianhua Ma, Doctor
Phone 8625-52887091
Email majianhua196503@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will assess the serum expression of MMP-9 in normal people, type 2 diabetic patients and type 2 diabetic patients with atherosclerosis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date December 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- volunteer to participate and be able to sign informed consent prior to the trial.

- patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any drugs.

- The patients have completed carotid ultrasound during hospitalization.

Exclusion Criteria:

- patients with any antidiabetic drugs.

- impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.

- drug abuse and alcohol dependence in the past 5 years.

- systemic hormone therapy was used in the last three months.

- patients with infection and stress within 4 weeks.

- any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• diagnosed as type 2 diabetes without atherosclerosis
patients diagnosed as type 2 diabetes without atherosclerosis
• diagnosed as type 2 diabetes with atherosclerosis
patients diagnosed as type 2 diabetes with atherosclerosis
• people without type 2 diabetes or atherosclerosis
normal people without type 2 diabetes or atherosclerosis

Locations
Country Name City State
China Nanjing First Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Majianhua

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary total MMP-9 levels the different group of total MMP-9 levels 6 months
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