Chronic Subdural HematomaDISHNCT05599217
Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
An observational study of Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 4 sites in China.
Trial summary
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Dietary and nutritional questionnaire, Neurological function, cognitive function, and life quality assessment and Peripheral blood test
- How many people
- 420 participants
- Where
- 4 sitesChina
- Study dates
- 13 Mar 2023to 31 Mar 2025
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.
Who may be able to join
- Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- CSDH verified on cranial computed tomography or magnetic resonance imaging.
- Written informed consent from patients or their next of kin according to the patient's cognitive status.
- Control group (Healthy group)
- non-CSDH patients (18 years to 90 years) with matched age and gender.
- Written informed consent from patients or their next of kin according to the patient's cognitive status.
Who cannot join
- Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before.
- CSDH turned from acute subdural hematoma.
- Existing malignant tumors, poor medication condition or severe comorbidity.
- Difficulty in feeding requiring long-term enteral or parenteral nutrition support.
- Dietary and nutritional survey is estimated to be completed difficultly.
- Reproductive-age women without verified negative pregnancy testing.
- Participating in other research.
Trial locations and contacts
4 sites in 1 country.
Zhaofeng Zhang, Ph.D. contact
China4 sites, 4 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Liang Wu, M.D., +8615001333582, jasewl@sina.com
Weiming Liu, M.D.
- Recruiting
Huangshan City People's Hospital
Huangshan City, Anhui
Jianbo Fang, M.D., 15105590826 ext. +86, drfantasy@139.com
Xianqing Fang, M.D.
- Recruiting
First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Hui Zhou, M.D., 18961326536 ext. +86, lygzhouhui@163.com
Hui Zhou, M.D.
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia
Min Li, M.D.
Dongming Ma, M.D.
About this study
Official title: Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
Read the detailed description
Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Dietary and nutritional questionnaire, Neurological function, cognitive function, and life quality assessment, Peripheral blood test, Metabonomic test, Hematoma test
- Keywords
- Chronic subdural hematoma, Dietary inflammatory index, Food frequency questionnaire, Modified frailty index
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and nutritional questionnaireOther
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
Neurological function, cognitive function, and life quality assessmentOther
Neurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire.
Peripheral blood testOther
Collect peripheral blood samples from patients.
Metabonomic testOther
Collect urine and stool samples from patients.
Hematoma testOther
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
| Study group | Role | What they receive |
|---|---|---|
| Case group (CSDH group) | CSDH patients recruited from neurosurgical department at 4 medical centres in China, which have apparent clinical symptoms and are confirmed by computed tomography or magnetic resonance imaging. Receives: Other: Dietary and nutritional questionnaire; Other: Neurological function, cognitive function, and life quality assessment; Other: Peripheral blood test; Other: Metabonomic test; Other: Hematoma test | |
| Control group (Healthy group) | non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China. Receives: Other: Dietary and nutritional questionnaire; Other: Peripheral blood test; Other: Metabonomic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in dietary intakes
Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.
Measured: When subjects are enrolled
Difference in Dietary Inflammatory Index score
The Dietary Inflammatory Index (DII) score of the current nutritional status of patients with and without CSDH will be evaluated. The amounts of nutrients will be calculated using last 3-month nutrient analysis program. DII score will calculate from these foods. The z-score must first be calculated. To calculate the z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet.
Measured: When subjects are enrolled
Difference in nutritional status
Difference in nutritional status measured by Mini-Nutritional Assessment.
Measured: When subjects are enrolled
Difference in frailty status
Difference in frailty status measured by Modified Frailty Index. Modified Frailty Index ranges from score 0 to 1, and frail status is defined as a score of ≥0.27.
Measured: When subjects are enrolled
Secondary outcomes (2)
Difference in gut microbiota measured by 16S rRNA between case group and control group
Fecal sample will be measured by 16S rRNA sequencing. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample. The PCA, PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Measured: When subjects are enrolled
Difference in metabolomics of gut, urine, and serum between case group and control group
Changes of metabolites in gut, urine, and serum will be measured by metabolomic mass spectrometry.
Measured: When subjects are enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start13 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Liu, Beijing Tiantan Hospital
- Investigators
- Weiming Liu, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599217
- Sponsor's protocol ID
- HX-B-2022062
- Acronym
- DISH
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
- ClinicalTrials.gov ID
- NCT05599217
- Acronym / sponsor ID
- DISH / HX-B-2022062
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Dietary inflammatory index, Food frequency questionnaire, Modified frailty index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 31 Oct 2022 (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.
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
Detailed description
Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (CSDH group) | – | Other: Dietary and nutritional questionnaire, Other: Neurological function, cognitive function, and life quality assessment, Other: Peripheral blood test, Other: Metabonomic test, Other: Hematoma testCSDH patients recruited from neurosurgical department at 4 medical centres in China, which have apparent clinical symptoms and are confirmed by computed tomography or magnetic resonance imaging. |
| Control group (Healthy group) | – | Other: Dietary and nutritional questionnaire, Other: Peripheral blood test, Other: Metabonomic testnon-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.
Key inclusion criteria (6 listed)
- Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- CSDH verified on cranial computed tomography or magnetic resonance imaging.
- Written informed consent from patients or their next of kin according to the patient's cognitive status.
- Control group (Healthy group)
- non-CSDH patients (18 years to 90 years) with matched age and gender.
Key exclusion criteria (7 listed)
- Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before.
- CSDH turned from acute subdural hematoma.
- Existing malignant tumors, poor medication condition or severe comorbidity.
- Difficulty in feeding requiring long-term enteral or parenteral nutrition support.
- Dietary and nutritional survey is estimated to be completed difficultly.
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 |
|---|---|---|
| Dietary and nutritional questionnaireNutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires. | Other | Case group (CSDH group), Control group (Healthy group) |
| Neurological function, cognitive function, and life quality assessmentNeurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire. | Other | Case group (CSDH group) |
| Peripheral blood testCollect peripheral blood samples from patients. | Other | Case group (CSDH group), Control group (Healthy group) |
| Metabonomic testCollect urine and stool samples from patients. | Other | Case group (CSDH group), Control group (Healthy group) |
| Hematoma testCollect hematoma fluid, dura mater, and hematoma outer membrane samples from patients. | Other | Case group (CSDH group) |
Primary outcome
Difference in dietary intakes
Time frame: When subjects are enrolled
Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.
Difference in Dietary Inflammatory Index score
Time frame: When subjects are enrolled
The Dietary Inflammatory Index (DII) score of the current nutritional status of patients with and without CSDH will be evaluated. The amounts of nutrients will be calculated using last 3-month nutrient analysis program. DII score will calculate from these foods. The z-score must first be calculated. To calculate the z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet.
Difference in nutritional status
Time frame: When subjects are enrolled
Difference in nutritional status measured by Mini-Nutritional Assessment.
Difference in frailty status
Time frame: When subjects are enrolled
Difference in frailty status measured by Modified Frailty Index. Modified Frailty Index ranges from score 0 to 1, and frail status is defined as a score of ≥0.27.
2 secondary outcomes
Difference in gut microbiota measured by 16S rRNA between case group and control group
Time frame: When subjects are enrolled
Difference in metabolomics of gut, urine, and serum between case group and control group
Time frame: When subjects are enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.
Zhaofeng Zhang, Ph.D. contact
Weiming Liu, M.D. principal investigator
Beijing Tiantan Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 4 sites 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 6 inclusion and 7 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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Liang Wu, M.D. (15001333582 ext. +86, jasewl@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in dietary intakes (time frame: When subjects are enrolled). The study lists 4 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 22 Apr 2024.