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Assessment of Serum Leptin in Vitiligo Patients

Primary Purpose

Vitiligo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serum leptin
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with other autoimmune diseases

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

group A

group b

group C

group D

Arm Description

obese with vitligo

obese without vitligo

non obese with vitiligo

non obese without vitiligo

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
September 18, 2022
Last Updated
September 18, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05549869
Brief Title
Assessment of Serum Leptin in Vitiligo Patients
Official Title
Assessment of Serum Leptin in Vitiligo Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
obese with vitligo
Arm Title
group b
Arm Type
Active Comparator
Arm Description
obese without vitligo
Arm Title
group C
Arm Type
Active Comparator
Arm Description
non obese with vitiligo
Arm Title
group D
Arm Type
Active Comparator
Arm Description
non obese without vitiligo
Intervention Type
Diagnostic Test
Intervention Name(s)
serum leptin
Intervention Description
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
Primary Outcome Measure Information:
Title
level of serum leptin
Description
Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with vitiligo who are above the age of 18 years Exclusion Criteria: Patients with other autoimmune diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
doaa z amin, resident
Phone
01019096561
Email
doaa_zaghloul_post@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
wafaa m Abdel- majeed, Ass.Professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy m amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32155629
Citation
Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.
Results Reference
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PubMed Identifier
34724392
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.
Results Reference
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PubMed Identifier
35169000
Citation
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.
Results Reference
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PubMed Identifier
33807959
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):2639. doi: 10.3390/ijms22052639.
Results Reference
background
PubMed Identifier
29248361
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.
Results Reference
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Assessment of Serum Leptin in Vitiligo Patients

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