Role of Estrogen in the Flarring up of Lupus Nepheritis

NCT ID: NCT04468438

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-03-01

Brief Summary

Role of estrogen in the flarring up of lupus nepheritis

Detailed 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

Conditions

Activity of Lupus Nepheritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

50 patients with LN with regular menstrual cycle

1- First group of50 patients with regular menstrual cycle

serum estrogen and urinary albumin creatinine ratio

Intervention Type: DIAGNOSTIC_TEST

serum estrogen and urinary albumin creatinine ratio

50 patients with LN with amenorrhea

2- Second group of 50 patients with amenorrhea.

serum estrogen and urinary albumin creatinine ratio

Intervention Type: DIAGNOSTIC_TEST

serum estrogen and urinary albumin creatinine ratio

Interventions

serum estrogen and urinary albumin creatinine ratio

serum estrogen and urinary albumin creatinine ratio

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hager Zanaty Abdelraouf

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

hager zanaty, resident doctor

Role: CONTACT

hagerzanatyabd@gmail.com

01091250220

samir kamal, Assistant prof

Role: CONTACT

samirkotb45@yahoo.com

01062949199

References

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.

Reference Type: BACKGROUND

PMID: 24504809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27863914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22674006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21457530 (View on PubMed)

Other Identifiers

Example 3

Identifier Type: -

Identifier Source: org_study_id