Clinical trial NCT05549869: Assessment of Serum Leptin in Vitiligo Patients
Official title: Assessment of Serum Leptin in Vitiligo Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with other autoimmune diseases

Primary outcomes:
measure: level of serum leptin
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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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.