NCT04424706

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 7, 2020

Last Update Submit

June 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • total MMP-9 levels

    the different group of total MMP-9 levels

    6 months

Study Arms (3)

Normal people

No diabetes and atherosclerosis

Diagnostic Test: 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

type 2 diabetes mellitus with atherosclerosis

Newly diagnosed type 2 diabetes with atherosclerosis

Diagnostic Test: diagnosed as type 2 diabetes with atherosclerosis

Interventions

patients diagnosed as type 2 diabetes without atherosclerosis

type 2 diabetes mellitus without atherosclerosis

patients diagnosed as type 2 diabetes with atherosclerosis

type 2 diabetes mellitus with atherosclerosis

normal people without type 2 diabetes or atherosclerosis

Normal people

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

Related Publications (1)

  • Liu B, Su L, Loo SJ, Gao Y, Khin E, Kong X, Dalan R, Su X, Lee KO, Ma J, Ye L. Matrix metallopeptidase 9 contributes to the beginning of plaque and is a potential biomarker for the early identification of atherosclerosis in asymptomatic patients with diabetes. Front Endocrinol (Lausanne). 2024 Apr 10;15:1369369. doi: 10.3389/fendo.2024.1369369. eCollection 2024.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for testing the MMP-9 level

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jianhua Ma, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department of Endocrinology

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

June 30, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations