Assessment of Serum Leptin in Vitiligo Patients

Vitiligo Clinical Trial

Official title:

Assessment of Serum Leptin in Vitiligo Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05549869
• Other study ID #: soh-med-22-09-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: Sohag University
• Contact: doaa z amin, resident
• Phone: 01019096561
• Email: doaa_zaghloul_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .

Description:

, leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators such as tumor necrosis factor α "TNF," IL-2 and IL-6, as well as enhancing cytotoxic T cells "CD8" recruitment and inhibiting the functions of regulatory T cells "Tregs". Leptin can also aid in induction of oxidative stress by activating nicotinamide adenine dinucleotide phosphate (NADPH) oxidase• Venous blood samples will be taken from patients and controls to evaluate serum leptin: Morning samples will be taken after 12-h overnight fast in plain vacutainer tubes and directly centrifuged (1098 g for 15 min).

• Sera will be then collected in plain, capped, 5 ml centrifuge tubes "Eppendorf" and freezed at -20ᵒC in a well-monitored freezer until the analysis is performed• Serum leptin will be quantitatively assessed in vitro using DRG leptin Sandwich Enzyme Linked Immuno-Sorbent Assay "ELISA".

• ELISA will be performed according to manufacturer's guidelines where each run included a standard curve.

• Using the mean absorbance value for each sample, the corresponding concentration from the standard curve will be determined.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with vitiligo who are above the age of 18 years

Exclusion Criteria:

• Patients with other autoimmune diseases

Related Conditions & MeSH terms

• Vitiligo

Intervention

Diagnostic Test:
• serum leptin
Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Aryanian Z, Shirzadian A, Farzaneh S, Goodarzi A, Azizpour A, Hatami P. Metabolic derangement in patients with vitiligo: a cross-sectional study. J Investig Med. 2022 Apr;70(4):963-966. doi: 10.1136/jim-2021-002062. Epub 2022 Feb 15. — View Citation

Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10. Review. — View Citation

de Oliveira Dos Santos AR, de Oliveira Zanuso B, Miola VFB, Barbalho SM, Santos Bueno PC, Flato UAP, Detregiachi CRP, Buchaim DV, Buchaim RL, Tofano RJ, Mendes CG, Tofano VAC, Dos Santos Haber JF. Adipokines, Myokines, and Hepatokines: Crosstalk and Metabolic Repercussions. Int J Mol Sci. 2021 Mar 5;22(5). pii: 2639. doi: 10.3390/ijms22052639. Review. — View Citation

Mechanick JI, Zhao S, Garvey WT. Leptin, An Adipokine With Central Importance in the Global Obesity Problem. Glob Heart. 2018 Jun;13(2):113-127. doi: 10.1016/j.gheart.2017.10.003. Epub 2017 Dec 13. Review. — View Citation

Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021 Dec 20;39(36):4073-4126. doi: 10.1200/JCO.21.01440. Epub 2021 Nov 1. Erratum in: J Clin Oncol. 2022 Jan 20;40(3):315. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of serum leptin	Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .	6 month