The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis

June 8, 2020 updated by: Majianhua

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal control group, newly diagnosis of type 2 diabetes mellitus with atherosclerosis, newly diagnosis of type 2 diabetes mellitus without atherosclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal people
No diabetes and atherosclerosis
Diagnostic test: people without type 2 diabetes or atherosclerosis
normal people without type 2 diabetes or atherosclerosis
type 2 diabetes mellitus without atherosclerosis
Newly diagnosed type 2 diabetes without atherosclerosis
Diagnostic test: diagnosed as type 2 diabetes without atherosclerosis
patients diagnosed as type 2 diabetes without atherosclerosis
type 2 diabetes mellitus with atherosclerosis
Newly diagnosed type 2 diabetes with atherosclerosis
Diagnostic test: diagnosed as type 2 diabetes with atherosclerosis
patients diagnosed as type 2 diabetes with atherosclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total MMP-9 levels
Time Frame: 6 months
the different group of total MMP-9 levels
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Majianhua

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20200320-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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