NCT03622320

Brief Summary

This study aims at detection of possible associated metabolic syndrome with vitiligo and assessment of possible contribution of the age of onset of vitiligo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

April 24, 2025

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

July 16, 2018

Last Update Submit

April 22, 2025

Conditions

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

  • Central obesity as a Metabolic risk in vitiligo patients

    Central obesity will be assessed using waist circumference in cm in vitiligo patients and control group as a risk factor for metabolic syndrome

    one year

Secondary Outcomes (8)

  • Arterial Blood Pressure as a Metabolic risk in vitiligo patients

    one year

  • Fasting Blood pressure as a Metabolic risk in vitiligo patients

    one year

  • Serum Triglycerides and HDL

    one year

  • Body mass index as a Metabolic risk in vitiligo patients

    one year

  • Detection of insulin resistance in patients with vitiligo

    one year

  • +3 more secondary outcomes

Study Arms (2)

Vitiligo patients

Vitiligo patients (100 NSV and 50 segmental) who will be further classified according to age of onset and blood sample will be taken

Other: Blood sample

controls

Matching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken

Other: Blood sample

Interventions

Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin

Vitiligo patientscontrols

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, Cairo University).

You may qualify if:

  • Both genders
  • Patients with non-segmental vitiligo (NSV) and segmental vitiligo

You may not qualify if:

  • Smoking
  • Pregnancy
  • Systemic steroid intake in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals, dermatology outpatient clinic

Cairo, Egypt

Location

Related Publications (1)

  • Ibrahim S, El-Tahlawi S, Mogawer RM, El Ansary M, Esmat S, El-Hawary M. Different vitiligo characteristics as predictors of increased risk of metabolic syndrome and insulin resistance: A case-control study. J Cosmet Dermatol. 2022 Dec;21(12):7170-7177. doi: 10.1111/jocd.15446. Epub 2022 Oct 25.

MeSH Terms

Conditions

Metabolic SyndromeVitiligoInsulin Resistance

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Samar El-Tahlawi, MD

    Cairo university, dermatology department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 9, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

April 24, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations