Clinical trial NCT03622320: Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
Official title: Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Vitiligo
Keywords: insulin resistance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Central obesity as a Metabolic risk in vitiligo patients
timeFrame: one year
Secondary outcomes:
measure: Arterial Blood Pressure as a Metabolic risk in vitiligo patients
timeFrame: one year
measure: Fasting Blood pressure as a Metabolic risk in vitiligo patients
timeFrame: one year
measure: Serum Triglycerides and HDL
timeFrame: one year
measure: Body mass index as a Metabolic risk in vitiligo patients
timeFrame: one year
measure: Detection of insulin resistance in patients with vitiligo
timeFrame: one year
measure: Correlation between extent/ severity/duration/ activity of vitiligo and possible associated metabolic derangements.
timeFrame: one year
measure: Correlation between extent/ severity/duration/ activity of vitiligo and the age of onset.
timeFrame: one year
measure: Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals, dermatology outpatient clinic
Study officials:
affiliation: Cairo university, dermatology department
name: Samar El-Tahlawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.