Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

NCT05599217 | Recruiting DMC

• 1 other identifier: HX-B-2022062
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Dietary inflammatory index; Food frequency questionnaire; Modified frailty index

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Difference in nutritional status

  Difference in nutritional status measured by Mini-Nutritional Assessment.

  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.

  When subjects are enrolled

Secondary Outcomes (2)

• Difference in gut microbiota measured by 16S rRNA between case group and control group

  When subjects are enrolled

• Difference in metabolomics of gut, urine, and serum between case group and control group

  When subjects are enrolled

Study Arms (2)

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.

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.

Other: Dietary and nutritional questionnaire; Other: Peripheral blood test; Other: Metabonomic test

Interventions

Dietary and nutritional questionnaire OTHER

Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.

Case group (CSDH group); Control group (Healthy group)

Neurological function, cognitive function, and life quality assessment OTHER

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.

Case group (CSDH group)

Peripheral blood test OTHER

Collect peripheral blood samples from patients.

Case group (CSDH group); Control group (Healthy group)

Metabonomic test OTHER

Collect urine and stool samples from patients.

Case group (CSDH group); Control group (Healthy group)

Hematoma test OTHER

Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Case group (CSDH group)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (4)

Huangshan City People's Hospital

Huangshan City, Anhui, China

RECRUITING

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Chronic subdural hematoma group: * vein blood * stool * urine * hematoma fluid * dura mater * hematoma outer membrane Healthy control group: * vein blood * stool * urine

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Diet; Nervous System Physiological Phenomena

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Weiming Liu, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wu, M.D.

CONTACT

15001333582; jasewl@sina.com

Zhaofeng Zhang, Ph.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 31, 2022
• Study Start: March 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)