Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo

Metabolic Syndrome Clinical Trial

Official title:

Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622320
• Other study ID #: Vitiligo & Metabolic syndrome
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome
• Vitiligo

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university hospitals, dermatology outpatient clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Detection of insulin resistance in patients with vitiligo	This is via measuring HOMA-IR	one year
Secondary	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
Secondary	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
Secondary	Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression	This via directly addressing dietary habits	one year