Role of Estrogen in the Flarring up of Lupus Nepheritis

Activity of Lupus Nepheritis Clinical Trial

Official title:

Role of Estrogen in the Flarring up of Lupus Nepheritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04468438
• Other study ID #: Example 3
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2019
• Source: Assiut University
• Contact: hager zanaty, resident doctor
• Phone: 01091250220
• Email: hagerzanatyabd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Role of estrogen in the flarring up of lupus nepheritis

Description:

Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000 individuals worldwide . SLE is characterized by loss of tolerance against nuclear autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex disease, and multiorgan tissue inflammation. Up to 50% of SLE patients develop some degree of renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of poor prognosis and is a significant cause of morbidity and mortality . Because 9 of 10 SLE patients are women, the role of the sex hormones estrogens in this disease is of key interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as well as on most immune cells however the kidney is considered the most estrogenic nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and extends to menopause , supporting the concept that estrogens or other reproductive factors stimulate lupus development. This concept is further evidenced by reports of menstrual cycle flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE. There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive to the cytotoxic effects of UV light radiation

. RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that people were more likely to menstruate during a new moon, which occurs during the opposite half of the lunar cycle than the full moon . There are different evolutionary theories speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in length. Stories and beliefs connecting the two are also found in various cultures and mythologies . The terms menstruation and menses even come from Latin and Greek words meaning month mensis and moon mene

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients with SLE complicated with LN.

2. Patients with age more than 18 years old.

Exclusion Criteria:

• 1- Pragnancy, lactation. 2- Menpause. 3- Primary amenorrhea. 4- Patients with current use of oral contraceptive agents. 5- Patients who receive pulse therapy during the study

Related Conditions & MeSH terms

• Activity of Lupus Nepheritis

Intervention

Diagnostic Test:
• serum estrogen and urinary albumin creatinine ratio
serum estrogen and urinary albumin creatinine ratio

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med. 2012 Jun 6;18(6):871-82. doi: 10.1038/nm.2752. Review. — View Citation

Moulton VR, Tsokos GC. Abnormalities of T cell signaling in systemic lupus erythematosus. Arthritis Res Ther. 2011 Mar 17;13(2):207. doi: 10.1186/ar3251. Review. — View Citation

Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238. — View Citation

Tan DA, Haththotuwa R, Fraser IS. Cultural aspects and mythologies surrounding menstruation and abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:121-133. doi: 10.1016/j.bpobgyn.2016.09.015. Epub 2016 Oct 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy	Measurement of estrogen in the first day of menstruation and the14th day of menstruation To intensify treatment during days of menstruation or days of full moon.	one year