Metabolic SyndromeNCT03622320
Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
An observational study of Metabolic Syndrome and Vitiligo, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Vitiligo
- What is being tested?
- Blood sample
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, Cairo University).
Who may be able to join
- Both genders
- Patients with non-segmental vitiligo (NSV) and segmental vitiligo
Who cannot join
- Smoking
- Pregnancy
- Systemic steroid intake in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at detection of possible associated metabolic syndrome with vitiligo and assessment of possible contribution of the age of onset of vitiligo.
Read the 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.
- Conditions
- Metabolic Syndrome, Vitiligo
- Being tested
- Blood sample
- Keywords
- insulin resistance
- Medical subject headings
- Metabolic Syndrome, Vitiligo, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood sample | |
| controls | Matching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: one year
Detection of insulin resistance in patients with vitiligo
This is via measuring HOMA-IR
Measured: 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
Measured: 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
Measured: one year
Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression
This via directly addressing dietary habits
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mogawer, Cairo University
- Investigators
- Samar El-Tahlawi, MD, Principal investigator, Cairo university, dermatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622320
- Sponsor's protocol ID
- Vitiligo & Metabolic syndrome
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2018
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Dec;21(12):7170-7177. doi: 10.1111/jocd.15446. Epub 2022 Oct 25.
PubMed 36208004
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
- ClinicalTrials.gov ID
- NCT03622320
- Acronym / sponsor ID
- Vitiligo & Metabolic syndrome
- Conditions
- Metabolic Syndrome, Vitiligo
- Keywords
- insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo patients | – | Other: Blood sampleVitiligo patients (100 NSV and 50 segmental) who will be further classified according to age of onset and blood sample will be taken |
| controls | – | Other: Blood sampleMatching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, Cairo University).
Key inclusion criteria (2 listed)
- Both genders
- Patients with non-segmental vitiligo (NSV) and segmental vitiligo
Key exclusion criteria (3 listed)
- Smoking
- Pregnancy
- Systemic steroid intake in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin | Other | Vitiligo patients, controls |
Primary outcome
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
8 secondary outcomes
Arterial Blood Pressure as a Metabolic risk in vitiligo patients
Time frame: one year
Fasting Blood pressure as a Metabolic risk in vitiligo patients
Time frame: one year
Serum Triglycerides and HDL
Time frame: one year
Body mass index as a Metabolic risk in vitiligo patients
Time frame: one year
Detection of insulin resistance in patients with vitiligo
Time frame: one year
Correlation between extent/ severity/duration/ activity of vitiligo and possible associated metabolic derangements.
Time frame: one year
Correlation between extent/ severity/duration/ activity of vitiligo and the age of onset.
Time frame: one year
Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 36208004Ibrahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar El-Tahlawi, MD principal investigator
Cairo university, dermatology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Vitiligo, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central obesity as a Metabolic risk in vitiligo patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.