CKDNCT03277911
Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases
An observational study of CKD, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CKD
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2017to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Patients with CKD stage (1-5).
- Not known thyroid disorders.
- Not in lipid lowering agents.
Who cannot join
- Patients with known thyroid disorders, on medication affecting thyroid function and lipid lowering agents are excluded from the study.
- CKD patients who were or underwent previous dialysis.
- Nephrotic syndrome.
- Obesity.
- Patients on estrogens, corticosteroids, antithyroid drugs, dietary supplements.
- Pregnant woman
About this study
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.
Read the 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.
- Conditions
- CKD
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will be conducted to investigate thyroid function in patients with chronic kidney disease
serum urea, creatinine, , triiodothyronine [T3], free thyroxin [T4], thyroid stimulating hormones [TSH]
Measured: one year
The study will be conducted to investigate lipid profile in patients with chronic kidney disease
serum urea, creatinine,high density lipoprotein [HDL] cholesterol, low density cholesterol, total cholesterol, triglyceride
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start10 Sep 2017 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Elewa Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277911
- Sponsor's protocol ID
- Clincal Pathology
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT03277911
- Acronym / sponsor ID
- Clincal Pathology
- Conditions
- CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2017 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- Patients with CKD stage (1-5).
- Not known thyroid disorders.
- Not in lipid lowering agents.
Key exclusion criteria (6 listed)
- Patients with known thyroid disorders, on medication affecting thyroid function and lipid lowering agents are excluded from the study.
- CKD patients who were or underwent previous dialysis.
- Nephrotic syndrome.
- Obesity.
- Patients on estrogens, corticosteroids, antithyroid drugs, dietary supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
Related trials for CKD
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will be conducted to investigate thyroid function in patients with chronic kidney disease (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.