Irisin Gene Polymorphism in Type II Diabetic PatientsCADNCT04957823
Irisin Expression and Gene Polymorphism in Type II Diabetic Patients With and Without CAD
An observational study of Irisin Gene Polymorphism in Type II Diabetic Patients, run by Sohag University at 1 site in Egypt.
Trial summary
This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irisin Gene Polymorphism in Type II Diabetic Patients
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 30 Oct 2023
- 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 70 years
- All sexes
- Adult, Older adult
Study population: type II diabetic patients with and without coronary artery disease in our center in sohag university hospital.
Who may be able to join
- This study will include type II diabetic patients aged between 18 and 45 years old
Who cannot join
- Recent acute myocardial infarction.
- patients with Heart Failure
- Active infection
- End stage renal failure (GFR < 30 ml/min) or on dialysis
- Liver cell failure
- Athletes or having heavy muscular exercise in the previous 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Irisin Level & FDNC5 Genetic Polymorphism Can Predict the Presence &Severity of Coronary Artery Disease in Patients With Type II DM?
This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diseased | type II diabetic patients with documented coronary artery disease. | |
| Control | type II diabetic patients without coronary artery disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irisin level
detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)
Measured: 6 months
FNDC5 Genotyping
whether homogenetic or heterogenetic
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 posted12 Jul 2021
- Study start20 Apr 2021
- Primary completion30 Aug 2022
- Study completion30 Oct 2023
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 Irisin Gene Polymorphism in Type II Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Morad Foad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957823
- Sponsor's protocol ID
- Soh-Med-21-06-20
- Acronym
- CAD
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Foad AM, Hafez A, Youssef W, Ahmed AE, Altaher AM. Irisin expression and FNDC5 (rs3480) gene polymorphism in type 2 diabetic patients with and without CAD. Arch Physiol Biochem. 2024 Oct;130(5):523-528. doi: 10.1080/13813455.2023.2173785. Epub 2023 Feb 2.
PubMed 36732920
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Irisin Level & FDNC5 Genetic Polymorphism Can Predict the Presence &Severity of Coronary Artery Disease in Patients With Type II DM?
- ClinicalTrials.gov ID
- NCT04957823
- Acronym / sponsor ID
- CAD / Soh-Med-21-06-20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 12 Jul 2021 (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.
This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diseased | – | –type II diabetic patients with documented coronary artery disease. |
| Control | – | –type II diabetic patients without coronary artery disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- type II diabetic patients with and without coronary artery disease in our center in sohag university hospital.
Key inclusion criteria (1 listed)
- This study will include type II diabetic patients aged between 18 and 45 years old
Key exclusion criteria (6 listed)
- Recent acute myocardial infarction.
- patients with Heart Failure
- Active infection
- End stage renal failure (GFR < 30 ml/min) or on dialysis
- Liver cell failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Irisin level
Time frame: 6 months
detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)
FNDC5 Genotyping
Time frame: 6 months
whether homogenetic or heterogenetic
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 29 Feb 2024.
- Derived from this study: PubMed 36732920Foad AM, Hafez A, Youssef W, Ahmed AE, Altaher AM. Irisin expression and FNDC5 (rs3480) gene polymorphism in type 2 diabetic patients with and without CAD. Arch Physiol Biochem. 2024 Oct;130(5):523-528. doi: 10.1080/13813455.2023.2173785. Epub 2023 Feb 2.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irisin Gene Polymorphism in Type II Diabetic Patients, run by Sohag 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 1 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: finished, as of the sponsor's last update on 29 Feb 2024. 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?
Irisin level (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04957823, 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 29 Feb 2024.