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Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo

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ClinicalTrials.gov Identifier: NCT03622320
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rania Mogawer, 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.

Condition or disease Intervention/treatment
Metabolic Syndrome Vitiligo 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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Central obesity as a Metabolic risk in vitiligo patients [ Time Frame: 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 :
  1. Arterial Blood Pressure as a Metabolic risk in vitiligo patients [ Time Frame: one year ]
    Arterial Blood Pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome

  2. Fasting Blood pressure as a Metabolic risk in vitiligo patients [ Time Frame: one year ]
    Fasting Blood pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome

  3. Serum Triglycerides and HDL [ Time Frame: one year ]
    Serum Triglycerides and HDL will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome

  4. Body mass index as a Metabolic risk in vitiligo patients [ Time Frame: one year ]
    Body Mass index in kg/m2 will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome

  5. Detection of insulin resistance in patients with vitiligo [ Time Frame: one year ]
    This is via measuring HOMA-IR

  6. Correlation between extent/ severity/duration/ activity of vitiligo and possible associated metabolic derangements. [ Time Frame: one year ]
    This via detecting VASI, VES and VIDA scores for vitiligo patients

  7. Correlation between extent/ severity/duration/ activity of vitiligo and the age of onset. [ Time Frame: one year ]
    This via detecting VASI, VES and VIDA scores for vitiligo patients and relating to the age of onset

  8. Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression [ Time Frame: one year ]
    This via directly addressing dietary habits



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, Cairo University).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622320


Contacts
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Contact: Rania Mogawer, MSc 01113363019 ext 002 raniamogawe88@gmail.com
Contact: Sarah Ismail, MD 01224247232 ext 002 sarah.ibrahim@kasralainy.edu.eg

Locations
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Egypt
Cairo university hospitals, dermatology outpatient clinic Recruiting
Cairo, Egypt
Contact: Rania Mogawer, MSc    01113363019 ext 002    raniamogawer88@gmail.com   
Contact: Sarah Ismail, MD    01224247232 ext 002    sarah.ibrahim@kasralainy.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Samar El-Tahlawi, MD Cairo university, dermatology department

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Responsible Party: Rania Mogawer, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03622320     History of Changes
Other Study ID Numbers: Vitiligo & Metabolic syndrome
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rania Mogawer, Cairo University:
insulin resistance
Additional relevant MeSH terms:
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Vitiligo
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hypopigmentation
Pigmentation Disorders
Skin Diseases