Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

Chronic Subdural Hematoma Clinical Trial

— DISH  

Official title:

Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599217
• Other study ID #: HX-B-2022062
• Status: Recruiting
• Start date: March 13, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: Liang Wu, M.D.
• Phone: 15001333582
• Email: jasewl[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Other:
• Dietary and nutritional questionnaire
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
• Neurological function, cognitive function, and life quality assessment
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 test
Collect peripheral blood samples from patients.
• Metabonomic test
Collect urine and stool samples from patients.
• Hematoma test
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing
China	Huangshan City People's Hospital	Huangshan	Anhui
China	First People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in dietary intakes	Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.	When subjects are enrolled
Primary	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.	When subjects are enrolled
Primary	Difference in nutritional status	Difference in nutritional status measured by Mini-Nutritional Assessment.	When subjects are enrolled
Primary	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.	When subjects are enrolled
Secondary	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.	When subjects are enrolled
Secondary	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.	When subjects are enrolled