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Clinical Trials/NCT05549869
NCT05549869Not yet recruitingNot Applicable

Assessment of Serum Leptin in Vitiligo Patients

Sohag University1 site in 1 country400 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
400
Locations
1
Primary Endpoint
level of serum leptin

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Patients with other autoimmune diseases

Arms & Interventions

group A

Active Comparator

obese with vitligo

Intervention: serum leptin (Diagnostic Test)

group b

Active Comparator

obese without vitligo

Intervention: serum leptin (Diagnostic Test)

group C

Active Comparator

non obese with vitiligo

Intervention: serum leptin (Diagnostic Test)

group D

Active Comparator

non obese without vitiligo

Intervention: serum leptin (Diagnostic Test)

Outcomes

Primary Outcomes

level of serum leptin

Time Frame: 6 month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Doaa Zaghloul Amin

dermatology and andrology resident in luxor international hospital

Sohag University

Study Sites (1)

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