- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06401122
Comparison of Dyslipidemia Among Diabetics Versus Non Diabetics in Haemodialysis Patients
May 2, 2024 updated by: Dina Ali Abudeif Zaharn, Assiut University
Comparison of Dyslipidemia Among Diabetics Versus Non Diabetics in Haemodialysis
- How dyslipidemia common among Diabetic and non- Diabetic Haemodialysis patients.
- How differ dyslipidemia types among Diabetic and non- Diabetic in Haemodialysis patients. (Qualitative difference).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: dina A. Abudeif, doctor
- Phone Number: +201141210144
- Email: dinaaliabudeif7@gmail.com
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
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
haemodialysis patients for more than six months, and is with diabetes related to affect prevalance of dyslipidemia among these patients
Description
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 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
diabetic dialysis patients
fifty diabetic patients on regular haemodialysis more than 6 months
|
process of filtering the blood of a person whose kidneys are not working normally from uremic toxins
|
|
Non-diabetic dialysis patients
fifty Non-diabetic patients on regular haemodialysis more than 6 months
|
process of filtering the blood of a person whose kidneys are not working normally from uremic toxins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dyslipidemia prevalence among Diabetic versus non- Diabetic Haemodialysis patients
Time Frame: baseline
|
haemodialysis patients for more than six months, and is with diabetes related to affect prevalance of dyslipidemia among these patients
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Salwa S. Elgendi, professor, Assiut University
- Study Director: Essam M. Abdel-Aziz, doctor, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
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 (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
May 2, 2024
First Submitted That Met QC Criteria
May 2, 2024
First Posted (Actual)
May 6, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dyslipidemia haemodialysis
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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