Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Vitiligo
• Intervention / Treatment: Other: Blood sample

Detailed Description

This study aims at detection of incidence of metabolic syndrome in vitiligo patients and possible contribution of the age of onset of the disease. This involves detection of waist circumference, body mass index, index of central obesity, systolic and diastolic arterial blood pressure, fasting blood sugar, high density lipoproteins and triglycerides, in addition to insulin resistance as Homeostatic Model Assessment- insulin resisitance (HOMA-IR) and serum leptin in vitiligo patients. The outcomes will be correlated to extent/ severity/duration/ activity of vitiligo as well as to the age of onset. This is assumed to be of profound impact on vitiligo patients by properly assessing these patients for associated metabolic risk factors and helping prevent such metabolic derangements by detection of possible contributing factors such as insulin resistance and high serum adipokines as leptin.

Since there is temporal relation between nutrition, metabolic derangements and skin diseases where nutritional deficiencies as minerals, vitamins and fatty acids can lead to cutaneous manifestations and , on the other hand; skin diseases could contribute to metabolic derangements and nutritional deficiencies, the investigator's study will focus on nutrition and dietary habits and there possible contribution to any associated metabolic risk in vitiligo patients.

This is likely to open new horizons in the management of vitiligo, possibly through control of metabolic syndrome risk factors and insulin resistance as well as revealing possible temporal relation to dietary habits that are overlooked in vitiligo patients.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university hospitals, dermatology outpatient clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin
controls; Matching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken	Other: Blood sample; Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Pressure as a Metabolic risk in vitiligo patients	Arterial Blood Pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome	one year
Fasting Blood pressure as a Metabolic risk in vitiligo patients	Fasting Blood pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome	one year
Serum Triglycerides and HDL	Serum Triglycerides and HDL will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome	one year
Body mass index as a Metabolic risk in vitiligo patients	Body Mass index in kg/m2 will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome	one year
Detection of insulin resistance in patients with vitiligo	This is via measuring HOMA-IR	one year
Correlation between extent/ severity/duration/ activity of vitiligo and possible associated metabolic derangements.	This via detecting VASI, VES and VIDA scores for vitiligo patients	one year
Correlation between extent/ severity/duration/ activity of vitiligo and the age of onset.	This via detecting VASI, VES and VIDA scores for vitiligo patients and relating to the age of onset	one year
Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression	This via directly addressing dietary habits	one year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Samar El-Tahlawi, MD, Cairo university, dermatology department

Publications and helpful links

General Publications

• 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 Oct 7. doi: 10.1111/jocd.15446. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: insulin resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Disease; Insulin Resistance; Hyperinsulinism; Pigmentation Disorders; Hypopigmentation; Syndrome; Metabolic Syndrome; Vitiligo
• Other Study ID Numbers: Vitiligo & Metabolic syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No