Lupus NephritisNCT05964751
the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients
An observational study of Lupus Nephritis, run by Sohag University at 1 site in Egypt.
Trial summary
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- lipid profile and fasting blood suger
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age less than 18 years . Patient not able and willing to give written informed consent. Patients with pregnancy, cancer and with viral infectious diseases. Patients with other autoimmune diseases rather than SLE.
Who may be able to join
- 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.
Who cannot join
- 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.
Trial locations and contacts
1 site in 1 country.
sahar a al-rahman, assistant professor contact
About this study
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10-15:1.
Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease .
Read more
Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment, depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy, etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the potentially life-threatening manifestations .
Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%.
Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria, pathologic casts) with or without a rise in serum creatinine. The specific criteria listed for renal involvement are a urine protein > 500 mg/dL or red blood cell casts, Lupus nephritis is often confirmed by kidney biopsy, with the results showing one or more of the classes of lupus nephritis.
The metabolic syndrome is a prevalent disorder which is defined by the presence of central obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in CVD morbidity and mortality. This syndrome plays a major role in the complex network of systemic pro-inflammatory and prothrombotic states involved in the development of CVD .
Compared with patients without Metabolic syndrome, SLE patients from the multinational, multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an increased number of recent disease flares, and had accrued more organ damage . Mok et al report that Metabolic syndrome is significantly associated with new organ damage, vascular events, and mortality in patients with SLE .
- Conditions
- Lupus Nephritis
- Being tested
- lipid profile, fasting blood suger
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid profileDiagnostic test
measuerments of lipid profile parameters to detect hyperlipidemia
fasting blood sugerDiagnostic test
measurment of fasting blood suger to detect hyprerglicemia
| Study group | Role | What they receive |
|---|---|---|
| patinets with lupus nephritis | patients diagnosed as lupus nehpritis Receives: Diagnostic Test: lipid profile; Diagnostic Test: fasting blood suger | |
| pathents without lupus nephritis | sle pathients not diagnosed as lupus nephritis Receives: Diagnostic Test: lipid profile; Diagnostic Test: fasting blood suger | |
| controls | controls will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history Receives: Diagnostic Test: lipid profile; Diagnostic Test: fasting blood suger |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile (triglycerides)
to detect triglycerides level as apart of diagnosis of metabolic syndrome
Measured: 1 year
blood pressure measurement
to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome
Measured: 1 year
fasting blood suger
measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome
Measured: 1 year
body mass index
measurement of weight \& height to detect body mass index as apart of diagnosis of metaboic syndrome
Measured: 1 year
protein creatinine ratio
to measure amount of protein in urine as apart of lupus nephritis
Measured: 1 year
anti nuclear antibody test by IF
this test to diagnose patient as SLE
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Eldin Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964751
- Sponsor's protocol ID
- soh-Med-23-07-15MS
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.
PubMed 19136143Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.
PubMed 24504808DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.
PubMed 14184513Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.
PubMed 22556106
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT05964751
- Acronym / sponsor ID
- soh-Med-23-07-15MS
- Conditions
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Jul 2023 (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.
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10-15:1.
Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease .
Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment, depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy, etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the potentially life-threatening manifestations .
Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%.
Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria, pathologic casts) with or without a rise in serum creatinine. The specific criteria listed for renal involvement are a urine protein > 500 mg/dL or red blood cell casts, Lupus nephritis is often confirmed by kidney biopsy, with the results showing one or more of the classes of lupus nephritis.
The metabolic syndrome is a prevalent disorder which is defined by the presence of central obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in CVD morbidity and mortality. This syndrome plays a major role in the complex network of systemic pro-inflammatory and prothrombotic states involved in the development of CVD .
Compared with patients without Metabolic syndrome, SLE patients from the multinational, multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an increased number of recent disease flares, and had accrued more organ damage . Mok et al report that Metabolic syndrome is significantly associated with new organ damage, vascular events, and mortality in patients with SLE .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patinets with lupus nephritis | – | Diagnostic Test: lipid profile, Diagnostic Test: fasting blood sugerpatients diagnosed as lupus nehpritis |
| pathents without lupus nephritis | – | Diagnostic Test: lipid profile, Diagnostic Test: fasting blood sugersle pathients not diagnosed as lupus nephritis |
| controls | – | Diagnostic Test: lipid profile, Diagnostic Test: fasting blood sugercontrols will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age less than 18 years . Patient not able and willing to give written informed consent. Patients with pregnancy, cancer and with viral infectious diseases. Patients with other autoimmune diseases rather than SLE.
Key inclusion criteria (1 listed)
- 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.
Key exclusion criteria (1 listed)
- 1. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipid profilemeasuerments of lipid profile parameters to detect hyperlipidemia | Diagnostic test | controls, pathents without lupus nephritis, patinets with lupus nephritis |
| fasting blood sugermeasurment of fasting blood suger to detect hyprerglicemia | Diagnostic test | controls, pathents without lupus nephritis, patinets with lupus nephritis |
Primary outcome
lipid profile (triglycerides)
Time frame: 1 year
to detect triglycerides level as apart of diagnosis of metabolic syndrome
blood pressure measurement
Time frame: 1 year
to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome
fasting blood suger
Time frame: 1 year
measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome
body mass index
Time frame: 1 year
measurement of weight \& height to detect body mass index as apart of diagnosis of metaboic syndrome
protein creatinine ratio
Time frame: 1 year
to measure amount of protein in urine as apart of lupus nephritis
anti nuclear antibody test by IF
Time frame: 1 YEAR
this test to diagnose patient as SLE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 19136143Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.
- Background: PubMed 24504808Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.
- Background: PubMed 14184513DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.
- Background: PubMed 22556106Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.
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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.
sahar a al-rahman, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact mohamed s ali, resident (01015159035, mohamedsalah@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid profile (triglycerides) (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964751, which also lists 4 linked publications.
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 28 Jul 2023.