Assessment of Serum Leptin in Vitiligo Patients

NCT ID: NCT05549869

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-09-30

Brief Summary

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

Detailed Description

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, 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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

obese with vitligo

Group Type ACTIVE_COMPARATOR

serum leptin

Intervention Type DIAGNOSTIC_TEST

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

group b

obese without vitligo

Group Type ACTIVE_COMPARATOR

serum leptin

Intervention Type DIAGNOSTIC_TEST

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

group C

non obese with vitiligo

Group Type ACTIVE_COMPARATOR

serum leptin

Intervention Type DIAGNOSTIC_TEST

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

group D

non obese without vitiligo

Group Type ACTIVE_COMPARATOR

serum leptin

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with other autoimmune diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Zaghloul Amin

dermatology and andrology resident in luxor international hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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doaa z amin, resident

Role: CONTACT

01019096561

wafaa m Abdel- majeed, Ass.Professor

Role: CONTACT

Facility Contacts

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Magdy m amin, professor

Role: primary

References

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

Reference Type BACKGROUND
PMID: 32155629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34724392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35169000 (View on PubMed)

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):2639. doi: 10.3390/ijms22052639.

Reference Type BACKGROUND
PMID: 33807959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29248361 (View on PubMed)

Other Identifiers

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soh-med-22-09-02

Identifier Type: -

Identifier Source: org_study_id

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