Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277911
Recruitment Status : Unknown
Verified September 2017 by Sara Elewa Ahmed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sara Elewa Ahmed, Assiut University

Brief Summary:
Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such disorders in CKD patients may be highly beneficial to slow progression of CKD. The study will be conducted to investigate thyroid function and lipid profile in patients with chronic kidney disease.

Condition or disease
CKD

Detailed Description:

Chronic kidney disease[CKD] is becoming a serious health problem.The number of people with impaired renal function is rapidly rising, especially in industrialized countries. It is increasing rapidly worldwide at an annual growth rate of 8%. Chronic kidney disease [CKD] is defined as kidney disease that has been present for months to years. Chronic kidney disease [CKD] is a complex disease impacting more than twenty million individuals. Progression of CKD is associated with a number of serious complications, including increased incidence of cardiovascular disease, hyperlipidemia, anemia and metabolic bone disease .CKD patients should be assessed for the presence of these complications and receive optimal treatment to reduce their morbidity and mortality .

CKD affects thyroid function in many ways, including low thyroid circulating hormone levels, altered peripheral hormone metabolism, insufficient binding to carrier proteins, reduced tissue thyroid hormone content and altered iodine storage in the thyroid gland.Thus,inCKD,thyroid hormone metabolism is impaired. . Hypothyroidism in patients with renal failure causes many metabolic and clinical problems, and both these diseases can mutually exacerbate their disturbances.. Chronic kidney disease has been known to affect thyroid hormones metabolism .Low serum level of T3 and T4 are most remarkable laboratorial finding. A high incidence of goiter and nodules on thyroid ultrasonography has been reported in patients with end stage renal failure[ESRF]. CKD is often associated with dyslipidemia. Several factors contribute to these changes. Patient with CKD have a reduction in the activity of lipoprotein lipase and hepatic triglyceride lipase. This interferes with uptake of triglyceride rich Apo lipoprotein B containing lipoprotein by the liver and in peripheral tissue, yielding increased circulation of these atherogenic lipoproteins. Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such disorders in CKD patients may be highly beneficial to slow progression of CKD.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases
Estimated Study Start Date : September 10, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : August 30, 2019





Primary Outcome Measures :
  1. The study will be conducted to investigate thyroid function in patients with chronic kidney disease [ Time Frame: one year ]
    serum urea, creatinine, , triiodothyronine [T3], free thyroxin [T4], thyroid stimulating hormones [TSH]

  2. The study will be conducted to investigate lipid profile in patients with chronic kidney disease [ Time Frame: one year ]
    serum urea, creatinine,high density lipoprotein [HDL] cholesterol, low density cholesterol, total cholesterol, triglyceride



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The study will be conducted on 80 patients with chronic kidney disease at Assuit University hospital to investigate thyroid function and lipid profile in patients with CKD of stages (1-5) and 20 subjects as a normal control. A total of newly diagnosed and known CKD cases of stage 1-5 will be included in the study.

Sample Size Calculation:

  • Group I: Controls-20 age and sex matched normal individuals.
  • Group II: Cases -40 patients with stage 1-3.
  • Group III: Cases -40 patients with stage 4 and 5
Criteria

Inclusion criteria:

  1. Patients with CKD stage (1-5).
  2. Not known thyroid disorders.
  3. Not in lipid lowering agents.

Exclusion Criteria:

  1. Patients with known thyroid disorders, on medication affecting thyroid function and lipid lowering agents are excluded from the study.
  2. CKD patients who were or underwent previous dialysis.
  3. Nephrotic syndrome.
  4. Obesity.
  5. Patients on estrogens, corticosteroids, antithyroid drugs, dietary supplements.
  6. Pregnant woman
Layout table for additonal information
Responsible Party: Sara Elewa Ahmed, Resident of clinical pathology department, Assiut University
ClinicalTrials.gov Identifier: NCT03277911    
Other Study ID Numbers: Clincal Pathology
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Dyslipidemias
Urologic Diseases
Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases