- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957823
Irisin Expression and Gene Polymorphism in Type II Diabetic Patients With and Without CAD (CAD)
February 27, 2024 updated by: Amera Morad Foad, Sohag University
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
100
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
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Sohag, Egypt
- Sohag uniersity hosoital
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
type II diabetic patients with and without coronary artery disease in our center in sohag university hospital.
Description
Inclusion Criteria:
- This study will include type II diabetic patients aged between 18 and 45 years old
Exclusion Criteria:
- 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
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: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Diseased
type II diabetic patients with documented coronary artery disease.
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Control
type II diabetic patients without coronary artery disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Irisin level
Time Frame: 6 months
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detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)
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6 months
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FNDC5 Genotyping
Time Frame: 6 months
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whether homogenetic or heterogenetic
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 20, 2021
Primary Completion (Actual)
August 30, 2022
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
July 3, 2021
First Submitted That Met QC Criteria
July 3, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-21-06-20
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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