Diabetes Mellitus, Type 2NCT03404037
Serum Endostatin Type 2 Diabetic Patients
An observational study of Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Arteriosclerosis
- What is being tested?
- serum endostatin level
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2017to 20 Dec 2017
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred ten out documented CAD subjects were divided into two groups; group I (Fifty-five CAD patients without T2DM) and group II (Fifty-five CAD patients with T2DM) addmitted to Zagazig University hospital. Egypt
Who may be able to join
None listed.
Who cannot join
- left ventricular ejection fraction (LVEF) ≤40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index < 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index >30 kg/m2 or < 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients With Coronary Heart Disease
To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.
Read the detailed description
elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.
- Being tested
- serum endostatin level
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum endostatin levelDiagnostic test
Also called Computed tomography
An oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding.
Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R\&D Systems, Minneapolis, Minnesota, USA
| Study group | Role | What they receive |
|---|---|---|
| Group I | Fifty-five coronary artery disease patients without type 2 DM Receives: Diagnostic Test: serum endostatin level | |
| Group II | Fifty-five coronary artery disease patients with type 2 DM Receives: Diagnostic Test: serum endostatin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease
Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients.
Measured: 3-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start2 Mar 2017
- Primary completion11 Nov 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Mohamed Elashmawy, Zagazig University
- Investigators
- Hazem M Elashmawy, MD. Msc, Principal investigator, Faculty of medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404037
- Sponsor's protocol ID
- 3527/20-2-2017
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03404037
- Acronym / sponsor ID
- 3527/20-2-2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 19 Jan 2018 (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.
To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.
Detailed description
elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: serum endostatin levelFifty-five coronary artery disease patients without type 2 DM |
| Group II | – | Diagnostic Test: serum endostatin levelFifty-five coronary artery disease patients with type 2 DM |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred ten out documented CAD subjects were divided into two groups; group I (Fifty-five CAD patients without T2DM) and group II (Fifty-five CAD patients with T2DM) addmitted to Zagazig University hospital. Egypt
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- left ventricular ejection fraction (LVEF) ≤40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index < 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index >30 kg/m2 or < 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.
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 |
|---|---|---|
| serum endostatin levelAlso: Computed tomographyAn oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding. Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R\&D Systems, Minneapolis, Minnesota, USA | Diagnostic test | Group I, Group II |
Primary outcome
Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease
Time frame: 3-Months
Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients.
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 19 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Hazem M Elashmawy, MD. Msc principal investigator
Faculty of medicine, Zagazig University
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 Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Zagazig University at 1 site in Egypt.
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 0 inclusion and 1 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 19 Jan 2018. 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 Egypt. 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?
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?
Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease (time frame: 3-Months). 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 19 Jan 2018.