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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06401122
Other study ID # Dyslipidemia haemodialysis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Assiut University
Contact dina A. Abudeif, doctor
Phone +201141210144
Email dinaaliabudeif7@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- How dyslipidemia common among Diabetic and non- Diabetic Haemodialysis patients. - How differ dyslipidemia types among Diabetic and non- Diabetic in Haemodialysis patients. (Qualitative difference).


Description:

Diabetes mellitus (DM) is a metabolic disease , a consequence of defects in insulin action, secretion, or both, and there are complications associated with it, such as nephropathy, retinopathy, neuropathy, cardiovascular complications ,cerebrovascular and peripheral arterial disease. Diabetic nephropathy, which occurs in about one third of type 2 diabetic patients, is the most common factor leading to end-stage renal disease (ESRD) . A very common metabolic abnormality associated with diabetes is dyslipidemia, which is characterized by a spectrum of quantitative and qualitative changes in lipids and lipoproteinsSeveral previous studies have pursued linking blood glucose levels to serum lipid activities. The etiology of dyslipidemia appears to be centered on the increased large TAG-rich very low-density lipoprotein-cholesterol (VLDL-C) and its impaired clearance. American diabetic association (ADA) defines dyslipidemia as hypercholesterolemia ≥200 mg/dl of serum total cholesterol, hypertriglyceridemia ≥150 mg/dl of serum triglyceride, reduced high density lipoprotein cholesterol (HDL-C) <40 mg/dl for men and <50 mg/dl for women, elevated low density lipoprotein cholesterol (LDL-C) ≥70 mg/dl and high TC to HDL-C ratio of ≥4.5. Normal plasma lipids and lipoprotein metabolism is critical for cellular cholesterol homeostasis and protection against atherosclerosis, renal disease and other complication . A study found that people with high blood pressure and overweight or obesity have a higher risk of developing dyslipidemia ,Early detection and effective control of blood lipid levels can reduce the morbidity and mortality of CVD in patients with DM. Therefore, it is important to determine the factors associated with dyslipidemia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 30, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients aged between 18 and 60 years. - Patients undergoing regular conventional Haemodialysis for more than 6 months Exclusion Criteria: - Peritoneal Dialysis - Haemodiafilteration - Acute Kidney Injury - Nephrotic syndrome - Hypothyroidism - Familial hypertriglyceridemia. - Acute pancreatitis - Connective tissue disease. - Decompensated liver disease - Active malignancy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
haemodialysis
process of filtering the blood of a person whose kidneys are not working normally from uremic toxins

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Ariyanti R, Besral B. Dyslipidemia Associated with Hypertension Increases the Risks for Coronary Heart Disease: A Case-Control Study in Harapan Kita Hospital, National Cardiovascular Center, Jakarta. J Lipids. 2019 Apr 30;2019:2517013. doi: 10.1155/2019/2517013. eCollection 2019. — View Citation

Biadgo B, Abebe SM, Baynes HW, Yesuf M, Alemu A, Abebe M. Correlation between Serum Lipid Profile with Anthropometric and Clinical Variables in Patients with Type 2 Diabetes Mellitus. Ethiop J Health Sci. 2017 May;27(3):215-226. doi: 10.4314/ejhs.v27i3.3. — View Citation

Hasan YK, Alsultan M, Anan MT, Hassn Q, Basha K. The prevalence of dyslipidemia in patients on hemodialysis: a cross-sectional study from Syria. Ann Med Surg (Lond). 2023 Jun 5;85(8):3838-3844. doi: 10.1097/MS9.0000000000000931. eCollection 2023 Aug. — View Citation

Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary dyslipidemia prevalence among Diabetic versus non- Diabetic Haemodialysis patients haemodialysis patients for more than six months, and is with diabetes related to affect prevalance of dyslipidemia among these patients baseline
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