- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470415
Relation of Epicardial Fat and Diabetic Nephropathy in Egyptian Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients attends to internal medicine, cardiology or nephrology outpatient clinics with the following criteria:
- Patients who are older than 30.
- Patients who are younger than 65.
- Patients with type 2 diabetes milletus.
- Patients with renal complaints (loin pain, frequency, ….).
- No sex predilection.
Exclusion Criteria:
Age:
Patients who are less than 30 years or more than 65 years.
- Patients with type 1 diabetes milletus or diabetes insipidus. 3. Patients with cardiac diseases: A. Patients with cardiac diseases ( coronary artery disease, heart failure, myocardial infarction, infection,…) or history of cardiac problem or previous intervention (PCI,..) will be excluded from our study.
B. Patients with cardiac congenital anomalies. 4. Patients with active infections. 5- Patients with autoimmune diseases: As rheumatoid arthritis or systemic lupus. 6- Patients with acute diabetic complications. 7- Patients with a family history of kidney failure. 8- Patients with other causes of nephropathy will be excluded as: A. Liver cirrhosis to exclude hepatorenal syndrome. B. Autoimmune diseases as lupus nephritis. C. History of excessive analgesics intake. D. End stage kidney disease (chronic renal failure on dialysis).
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Group A
Patients with type 2 diabetes milletus with normoalbuminuria.
|
Group B
Patients with type 2 diabetes milletus with microalbuminuria.
|
Group C
Patients with type 2 diabetes milletus with macroalbuminuria.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of protein in urine
Time Frame: 1 day
|
Urine analysis (for protein and creatinine): 24 hrs urine sample will be collected from all patients to detect presence and amount of protein in urine by dipstick or albumin in urine kits.
|
1 day
|
epicardial fat thickness measurement
Time Frame: 1 day
|
Echocardiography: Two dimensional echocardiography perpendicularly on the free wall of the right ventricle at end-systole in 3 cardiac cycles will be performed to all patients to measure the epicardial fat thickness.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
laboratory tests
Time Frame: 7 days
|
Fasting blood glucose, Blood sample for kidney function test, Blood sample for liver function test, C-reactive protein, complete blood count (blood sample on EDTA for calculating neutrophil lymphocyte ratio and platelet lymphocyte ratio) and HbA1c.
|
7 days
|
Imaging
Time Frame: 3 days
|
Abdominal ultrasound to assess the kidney and other abdominal organs condition, CT for selected cases only and echocardiography to assess the heart and great vessels condition and detect any disease or abnormality.
|
3 days
|
Calculation of GFR
Time Frame: 1 day
|
eGFR (Cockcroft-Gault equation) will be calculated by the following equation: GFR(ml/min)= ((140- age)Weight (kg))/(72XS.Cr (mg/dl)) For women,multiply with 0.85. *As weight in kilograms and creatinine in mg/dl. Patients will be instructed to fast overnight and not to eat cooked meat before the test. |
1 day
|
Full history taking
Time Frame: 1 day
|
Personal history: name, age, sex,….
and Disease history: onset, course, duration and stability, History of previous treatment and when it has been stopped and Family history of diabetes millets, cardiac or renal diseases will be taken
|
1 day
|
General examination
Time Frame: 1 day
|
General clinical examination will be carried out to detect any associated abnormalities in other body systems.
|
1 day
|
Electrocardiogram
Time Frame: 1 day
|
to assess the heart condition
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005 Apr 20;5:13. doi: 10.1186/1471-2288-5-13.
- Meenakshi K, Rajendran M, Srikumar S, Chidambaram S. Epicardial fat thickness: A surrogate marker of coronary artery disease - Assessment by echocardiography. Indian Heart J. 2016 May-Jun;68(3):336-41. doi: 10.1016/j.ihj.2015.08.005. Epub 2016 Jan 18.
- Iacobellis G, Willens HJ. Echocardiographic epicardial fat: a review of research and clinical applications. J Am Soc Echocardiogr. 2009 Dec;22(12):1311-9; quiz 1417-8. doi: 10.1016/j.echo.2009.10.013.
- Lim AKh. Diabetic nephropathy - complications and treatment. Int J Nephrol Renovasc Dis. 2014 Oct 15;7:361-81. doi: 10.2147/IJNRD.S40172. eCollection 2014.
- Akbas EM, Demirtas L, Ozcicek A, Timuroglu A, Bakirci EM, Hamur H, Ozcicek F, Turkmen K. Association of epicardial adipose tissue, neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio with diabetic nephropathy. Int J Clin Exp Med. 2014 Jul 15;7(7):1794-801. eCollection 2014.
- HILLER A, GREIF RL, BECKMAN WW. Determination of protein in urine by the biuret method. J Biol Chem. 1948 Dec;176(3):1421-9. No abstract available.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPICARDIALNEPHRO
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