Clinical trial NCT05599217: Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
Official title: Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Subdural Hematoma
Keywords: Chronic subdural hematoma
Dietary inflammatory index
Food frequency questionnaire
Modified frailty index
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.

Brief 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.

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.

Eligibility criteria: Case group (CSDH group)

Inclusion Criteria:

* 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)

Inclusion Criteria:

* 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.

Exclusion Criteria for both case and control group:

* 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.

Primary outcomes:
measure: Difference in dietary intakes
timeFrame: When subjects are enrolled
measure: Difference in Dietary Inflammatory Index score
timeFrame: When subjects are enrolled
measure: Difference in nutritional status
timeFrame: When subjects are enrolled
measure: Difference in frailty status
timeFrame: When subjects are enrolled
Secondary outcomes:
measure: Difference in gut microbiota measured by 16S rRNA between case group and control group
timeFrame: When subjects are enrolled
measure: Difference in metabolomics of gut, urine, and serum between case group and control group
timeFrame: When subjects are enrolled
Other outcomes:
Locations:
city: Huangshan
country: China
facility: Huangshan City People's Hospital
state: Anhui
city: Lianyungang
country: China
facility: First People's Hospital of Lianyungang
state: Jiangsu
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Weiming Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: