Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo

Completed

• Conditions: Metabolic Syndrome; Vitiligo
• Interventions: Other: Blood sample

• Registration Number: NCT03622320
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
controls	Blood sample	Matching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken
Vitiligo patients	Blood sample	Vitiligo patients (100 NSV and 50 segmental) who will be further classified according to age of onset and blood sample will be taken

Primary Outcome Measures

Name	Time	Method
Central obesity as a Metabolic risk in vitiligo patients	one year	Central obesity will be assessed using waist circumference in cm in vitiligo patients and control group as a risk factor for metabolic syndrome

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo university hospitals, dermatology outpatient clinic; 🇪🇬 Cairo, Egypt