ASDPBVTLCAASDNCT06188429
Peripheral Blood VA/TREM2 Levels and Their Correlation Analysis With the Development and Autistic Symptoms in Children With ASD
An observational study of ASD, run by Hua Wei at 1 site in China.
Trial summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social impairment, repetitive behaviors, and narrow interests. With advancements in diagnostic techniques, the prevalence of ASD has been increasing annually. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- ASD
- What is being tested?
- DSM-5
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 31 Oct 2024
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The Children's Health Department (Health Management Department) of Chongqing Medical University Affiliated Children's Hospital is recruiting 50 children with ASD and 50 typical children, aged between 3 and 8 years old. ASD diagnosis must comply with the DSM-5 diagnostic criteria.
Who may be able to join
- The Children's Health Department (Health Management Department) of Chongqing Medical University Affiliated Children's Hospital is recruiting 50 typical children and 50 children with ASD. Disease diagnosis will be conducted by professional doctors, and ASD diagnosis must comply with the DSM-5 diagnostic criteria.
Who cannot join
- Patients or their family members unable to cooperate with blood collection for testing are excluded. Exclusion criteria also involve a history of other neurological disorders, chromosomal diseases, genetic metabolic disorders, and other significant physical illnesses such as auditory or visual impairments, epilepsy, phenylketonuria, tuberous sclerosis, neurofibromatosis, severe head trauma, autoimmune diseases, and disorders related to the endocrine, cardiovascular, pulmonary, hepatic, or renal systems. Patients' legal guardians refusing to participate in the project are also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, 400000
wei Hua, 18580476890, weihua6280@163.com
About this study
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social impairment, repetitive behaviors, and narrow interests. With advancements in diagnostic techniques, the prevalence of ASD has been increasing annually. However, due to its complex and diverse etiology, there is no definitive consensus on the pathogenic mechanism of ASD. Numerous studies indicate that genetics, environment, and other factors play crucial roles in the onset of ASD.
Vitamin A (VA) exerts its effects in the body through its active metabolite, retinoic acid (RA), which regulates the transcriptional activity and expression of downstream genes by binding to retinoic acid receptors (RARs/RXRs). Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) is an immunoglobulin-like receptor present on microglial cells, with functions including inhibiting the production of inflammatory factors and engulfing apoptotic neurons. Recent foreign studies show a significant decrease in TREM2 levels in the brain tissue of ASD patients. However, there is limited research on the relationship between TREM2 and ASD.
Read more
In our previous animal experiments, we observed a reduction in TREM2 in the prefrontal cortex of the brain in ASD model rats. Administering overexpressed TREM2 improved autism-like behavior in ASD model rats, and supplementing RA upregulated the expression of RA-RARα and TREM2, modulated microglial cell activation, and improved autism-like behavior in rats. Therefore, we believe that the RA/RARα pathway regulates the TREM-2 signaling pathway, mediating changes in microglial cells, and TREM2 may be involved in the pathogenesis of ASD.
Soluble TREM2 (sTREM2) is formed by the extracellular domain shedding of TREM2 under the action of ADAM protease. Research indicates that the expression of sTREM2 can be detected in cerebrospinal fluid and plasma. However, the connection between VA, sTREM2 levels, and the behavioral and developmental levels of children with ASD remains unclear and requires further clinical research to validate. This will help deepen our understanding of TREM2 expression in ASD, its potential biological functions, and the role of RA.
- Conditions
- ASD
- Being tested
- DSM-5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM-5Diagnostic test
Using DSM-5 for diagnostic testing of the children in the study group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Children with ASD Receives: Diagnostic Test: DSM-5 | |
| Control Group | Normal Children Receives: Diagnostic Test: DSM-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood VA/sTREM2 level
Using an ELISA assay kit to detect the serum sTREM2 levels and employing high-performance liquid chromatography (HPLC) to measure the Vitamin A content in peripheral blood.
Measured: 3 months
Secondary outcomes (1)
Autistic Symptoms
Using the ADOS (Autism Diagnostic Observation Schedule) scale to analyze the severity of autism symptoms in autistic children.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start20 Nov 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Wei, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188429
- Sponsor's protocol ID
- (2023) Lund Review No.452
- Acronym
- PBVTLCAASD
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood VA/TREM2 Levels and Their Correlation Analysis With the Development and Autistic Symptoms in Children With ASD
- ClinicalTrials.gov ID
- NCT06188429
- Acronym / sponsor ID
- PBVTLCAASD / (2023) Lund Review No.452
- Conditions
- ASD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hua WeiUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social impairment, repetitive behaviors, and narrow interests. With advancements in diagnostic techniques, the prevalence of ASD has been increasing annually. However, due to its complex and diverse etiology, there is no definitive consensus on the pathogenic mechanism of ASD. Numerous studies indicate that genetics, environment, and other factors play crucial roles in the onset of ASD.
Vitamin A (VA) exerts its effects in the body through its active metabolite, retinoic acid (RA), which regulates the transcriptional activity and expression of downstream genes by binding to retinoic acid receptors (RARs/RXRs). Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) is an immunoglobulin-like receptor present on microglial cells, with functions including inhibiting the production of inflammatory factors and engulfing apoptotic neurons. Recent foreign studies show a significant decrease in TREM2 levels in the brain tissue of ASD patients. However, there is limited research on the relationship between TREM2 and ASD.
In our previous animal experiments, we observed a reduction in TREM2 in the prefrontal cortex of the brain in ASD model rats. Administering overexpressed TREM2 improved autism-like behavior in ASD model rats, and supplementing RA upregulated the expression of RA-RARα and TREM2, modulated microglial cell activation, and improved autism-like behavior in rats. Therefore, we believe that the RA/RARα pathway regulates the TREM-2 signaling pathway, mediating changes in microglial cells, and TREM2 may be involved in the pathogenesis of ASD.
Soluble TREM2 (sTREM2) is formed by the extracellular domain shedding of TREM2 under the action of ADAM protease. Research indicates that the expression of sTREM2 can be detected in cerebrospinal fluid and plasma. However, the connection between VA, sTREM2 levels, and the behavioral and developmental levels of children with ASD remains unclear and requires further clinical research to validate. This will help deepen our understanding of TREM2 expression in ASD, its potential biological functions, and the role of RA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Diagnostic Test: DSM-5Children with ASD |
| Control Group | – | Diagnostic Test: DSM-5Normal Children |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The Children's Health Department (Health Management Department) of Chongqing Medical University Affiliated Children's Hospital is recruiting 50 children with ASD and 50 typical children, aged between 3 and 8 years old. ASD diagnosis must comply with the DSM-5 diagnostic criteria.
Key inclusion criteria (1 listed)
- The Children's Health Department (Health Management Department) of Chongqing Medical University Affiliated Children's Hospital is recruiting 50 typical children and 50 children with ASD. Disease diagnosis will be conducted by professional doctors, and ASD diagnosis must comply with the DSM-5 diagnostic criteria.
Key exclusion criteria (1 listed)
- Patients or their family members unable to cooperate with blood collection for testing are excluded. Exclusion criteria also involve a history of other neurological disorders, chromosomal diseases, genetic metabolic disorders, and other significant physical illnesses such as auditory or visual impairments, epilepsy, phenylketonuria, tuberous sclerosis, neurofibromatosis, severe head trauma, autoimmune diseases, and disorders related to the endocrine, cardiovascular, pulmonary, hepatic, or renal systems. Patients' legal guardians refusing to participate in the project are also excluded.
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 |
|---|---|---|
| DSM-5Using DSM-5 for diagnostic testing of the children in the study group. | Diagnostic test | Control Group, Experimental Group |
Primary outcome
Blood VA/sTREM2 level
Time frame: 3 months
Using an ELISA assay kit to detect the serum sTREM2 levels and employing high-performance liquid chromatography (HPLC) to measure the Vitamin A content in peripheral blood.
1 secondary outcome
Autistic Symptoms
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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.
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 ASD, run by Hua Wei 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Hua (18580476890, weihua6280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood VA/sTREM2 level (time frame: 3 months). 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 3 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.