Type 2 DiabetesNCT04424706
The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis
An observational study of Type 2 Diabetes, run by Majianhua at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- diagnosed as type 2 diabetes without atherosclerosis, diagnosed as type 2 diabetes with atherosclerosis and people without type 2 diabetes or atherosclerosis
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 30 Dec 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal control group, newly diagnosis of type 2 diabetes mellitus with atherosclerosis, newly diagnosis of type 2 diabetes mellitus without atherosclerosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- diagnosed as type 2 diabetes without atherosclerosis, diagnosed as type 2 diabetes with atherosclerosis, people without type 2 diabetes or atherosclerosis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosed as type 2 diabetes without atherosclerosisDiagnostic test
patients diagnosed as type 2 diabetes without atherosclerosis
diagnosed as type 2 diabetes with atherosclerosisDiagnostic test
patients diagnosed as type 2 diabetes with atherosclerosis
people without type 2 diabetes or atherosclerosisDiagnostic test
normal people without type 2 diabetes or atherosclerosis
| Study group | Role | What they receive |
|---|---|---|
| Normal people | No diabetes and atherosclerosis Receives: Diagnostic Test: people without type 2 diabetes or atherosclerosis | |
| type 2 diabetes mellitus without atherosclerosis | Newly diagnosed type 2 diabetes without atherosclerosis Receives: Diagnostic Test: diagnosed as type 2 diabetes without atherosclerosis | |
| type 2 diabetes mellitus with atherosclerosis | Newly diagnosed type 2 diabetes with atherosclerosis Receives: Diagnostic Test: diagnosed as type 2 diabetes with atherosclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
total MMP-9 levels
the different group of total MMP-9 levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majianhua, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424706
- Sponsor's protocol ID
- KY20200320-01
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38660518
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04424706
- Acronym / sponsor ID
- KY20200320-01
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- MajianhuaUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal people | – | Diagnostic Test: people without type 2 diabetes or atherosclerosisNo diabetes and atherosclerosis |
| type 2 diabetes mellitus without atherosclerosis | – | Diagnostic Test: diagnosed as type 2 diabetes without atherosclerosisNewly diagnosed type 2 diabetes without atherosclerosis |
| type 2 diabetes mellitus with atherosclerosis | – | Diagnostic Test: diagnosed as type 2 diabetes with atherosclerosisNewly diagnosed type 2 diabetes with atherosclerosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal control group, newly diagnosis of type 2 diabetes mellitus with atherosclerosis, newly diagnosis of type 2 diabetes mellitus without atherosclerosis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| diagnosed as type 2 diabetes without atherosclerosispatients diagnosed as type 2 diabetes without atherosclerosis | Diagnostic test | type 2 diabetes mellitus without atherosclerosis |
| diagnosed as type 2 diabetes with atherosclerosispatients diagnosed as type 2 diabetes with atherosclerosis | Diagnostic test | type 2 diabetes mellitus with atherosclerosis |
| people without type 2 diabetes or atherosclerosisnormal people without type 2 diabetes or atherosclerosis | Diagnostic test | Normal people |
Primary outcome
total MMP-9 levels
Time frame: 6 months
the different group of total MMP-9 levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 38660518Liu 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.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Majianhua at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Ma, Doctor (8625-52887091, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total MMP-9 levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424706, which also lists 1 linked publication.
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 11 Jun 2020.