Metabolism Disorder, GlucoseNCT05968235
Correlation of Glucose and Lipid Metabolism Levels With Vitiligo
An observational study of Metabolism Disorder, Glucose and Metabolism Disorder, Lipid, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder, Glucose, Metabolism Disorder, Lipid, Vitiligo
- What is being tested?
- Collecting blood samples
- How many people
- 963 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 25 Mar 2023
- How long will I take part?
- 1 Year
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We recruited patients with clinically diagnosed vitiligo and age- and sex-matched healthy volunteers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Collecting blood samples
- Keywords
- Vitiligo, Glucose, Lipid
- Medical subject headings
- Glucose Metabolism Disorders, Lipid Metabolism Disorders, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | Patients diagnosed with vitiligo Receives: Other: Collecting blood samples | |
| Healthy | Healthy volunteers with sex- and age-matched with vitiligo patients Receives: Other: Collecting blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2020.02.01-2023.03.25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2020
- Primary completion25 Mar 2022
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism Disorder, GlucoseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- 963 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Chunying-1, Xijing Hospital
- Investigators
- Chunying Li, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968235
- Sponsor's protocol ID
- XJPF-LCY-V202307
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Glucose and Lipid Metabolism Levels and Vitiligo : a Case-control Study
- ClinicalTrials.gov ID
- NCT05968235
- Acronym / sponsor ID
- XJPF-LCY-V202307
- Keywords
- Vitiligo, Glucose, Lipid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 1 Aug 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo | – | Other: Collecting blood samplesPatients diagnosed with vitiligo |
| Healthy | – | Other: Collecting blood samplesHealthy volunteers with sex- and age-matched with vitiligo patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We recruited patients with clinically diagnosed vitiligo and age- and sex-matched healthy volunteers.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Collecting blood samplesPeripheral 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. | Other | Healthy, Vitiligo |
Primary outcome
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).
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.
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 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Chunying Li principal investigator
Air Force Military Medical University, China
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 Metabolism Disorder, Glucose and Metabolism Disorder, Lipid, run by Xijing Hospital at 1 site in China.
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 4 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 1 Aug 2023. 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 China. 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?
Demographic and epidemiological information of the study subjects (time frame: 2020.02.01-2023.03.25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.