Correlation of Glucose and Lipid Metabolism Levels With Vitiligo

July 21, 2023 updated by: Li Chunying-1, Xijing Hospital

Association of Glucose and Lipid Metabolism Levels and Vitiligo : a Case-control Study

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.

Study Overview

Detailed Description

Vitiligo is a common autoimmune skin disease, which causes white spot formation due to destruction of epidermal melanocytes, severely affecting the physical and mental health of patients, but treatment is extremely difficult due to unclear pathogenesis. Studies have reported that patients with type I diabetes mellitus combined with vitiligo, the risk of metabolic syndrome, diabetes mellitus, elevated lipids, and obesity in vitiligo patients is higher than that of healthy controls, and other studies have reported that vitiligo lesions in patients with hypercholesterolemia combined with vitiligo treated with simvastatin get rapid skin color, suggesting that there is a correlation between glucose and lipid metabolism and the vitiligo disease, but as of now there is no research study on the correlation of glucose and lipid metabolism and vitiligo pathogenesis, much less large data can be analyzed for reference. Therefore, there is an urgent need to study the metabolic profile of vitiligo patients and utilize the basic research platform to explore the role of abnormal body metabolism in the onset or progression of vitiligo.

This study intends to conduct a cross-sectional study, using questionnaires to collect and register vitiligo patients' disease information, etc., to establish a database of study subjects, and to collect peripheral blood samples from vitiligo patients to test the levels of key indicators of glycolipid and lipid metabolism, and to analyze their correlation with clinical features, disease activity, and treatment of vitiligo. Through the above studies, clinical evidence for the involvement of abnormalities in glycolipid and lipid metabolism in the development of vitiligo was provided.

Study Type

Observational

Enrollment (Actual)

963

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 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);
  2. Male or female subjects, age between 18 and 60 years old;
  3. Stable vital signs;
  4. Study subjects voluntarily signed an informed consent form.

Exclusion Criteria:

  1. 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;
  2. Women who are pregnant or breastfeeding shall be asked and determined by a clinician;
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vitiligo
Patients diagnosed with vitiligo
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.
Healthy
Healthy volunteers with sex- and age-matched with vitiligo patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic and epidemiological information of the study subjects
Time Frame: 2020.02.01-2023.03.25
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
Time Frame: 2020.02.01-2023.03.25
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Chunying Li, Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 25, 2022

Study Completion (Actual)

March 25, 2023

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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