NCT05968235

Brief Summary

The goal of this observational study is to compare serum glucose and lipid metabolism levels between health volunteers and vitiligo patients. The main question it aims to answer is whether vitiligo is related to glucose and lipid metabolism disorders. Participants will complete a vitiligo questionnaire and test serum levels of indicators related to glucose and lipid metabolism. Researchers will compare vitiligo patients with healthy volunteers to see if there is a correlation between vitiligo and disorders of glucose and lipid metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
963

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

July 21, 2023

Last Update Submit

July 21, 2023

Conditions

Keywords

VitiligoGlucoseLipid

Outcome Measures

Primary Outcomes (2)

  • Demographic and epidemiological information of the study subjects

    Detailed records of demographic information (age, gender, occupation, education degree, life history, et al.), clinical information of vitiligo (age at onset, duration, severity, type, treatment, complication, et al.) and physical examination index (height, weight, blood pressure, heart rate).

    2020.02.01-2023.03.25

  • Serum glucose and lipid metabolism levels of the study subjects

    Detection of fasting blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoproteins, and low-density lipoproteins in peripheral blood of study subjects.

    2020.02.01-2023.03.25

Study Arms (2)

Vitiligo

Patients diagnosed with vitiligo

Other: Collecting blood samples

Healthy

Healthy volunteers with sex- and age-matched with vitiligo patients

Other: Collecting blood samples

Interventions

Peripheral blood was collected from the study subjects and blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein levels were measured in the peripheral blood.

HealthyVitiligo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

We recruited patients with clinically diagnosed vitiligo and age- and sex-matched healthy volunteers.

You may qualify if:

  • Patients diagnosed as vitiligo by a dermatologist based on a combination of clinical manifestations (milky white or porcelain white patches), Wood's Lamp test results (bright white fluorescence), and histopathologic test results (reduction or disappearance of epidermal melanocytes in the white patches);
  • Male or female subjects, age between 18 and 60 years old;
  • Stable vital signs;
  • Study subjects voluntarily signed an informed consent form.

You may not qualify if:

  • Subjects who have been systematically using glucocorticoids, immunosuppressants, etc. that affect glycolipid levels due to a combination of diseases other than metabolic diseases in the last 3 months shall be asked and determined by a clinician;
  • Women who are pregnant or breastfeeding shall be asked and determined by a clinician;
  • Subjects who suffer from psychiatric disorders, etc. and who are not capable of cooperating with the follow-up study shall be asked and determined by a clinician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples of vitiligo patients and healthy volunteers

MeSH Terms

Conditions

Glucose Metabolism DisordersLipid Metabolism DisordersVitiligo

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesHypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chunying Li

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chief

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 1, 2023

Study Start

February 1, 2020

Primary Completion

March 25, 2022

Study Completion

March 25, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations