Assessment of Serum Leptin in Vitiligo Patients

Sohag University

Status: Not yet enrolling

Conditions: Vitiligo

Treatments: Diagnostic Test: serum leptin

Study type: Interventional

Funder types: Other

Identifiers

NCT05549869

soh-med-22-09-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with other autoimmune diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

group A

Active Comparator group

Description:

obese with vitligo

Treatment:

Diagnostic Test: serum leptin

group b

Active Comparator group

Description:

obese without vitligo

Treatment:

Diagnostic Test: serum leptin

group C

Active Comparator group

Description:

non obese with vitiligo

Treatment:

Diagnostic Test: serum leptin

group D

Active Comparator group

Description:

non obese without vitiligo

Treatment:

Diagnostic Test: serum leptin