Changes of Cognitive Function and Brain Magnetic Resonance in Maintenance Hemodialysis Patients With Diabetes Mellitus

NCT05953818 | Unknown

• 1 other identifier: 2022-P2-090-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

In recent years, due to the frequent occurrence of kidney disease and diabetes, the number of patients entering maintenance hemodialysis is increasing. With the economic development and dialysis quality improving year by year, the survival time of uremic patients is significantly prolonged, and the hazards of various complications are increasingly prominent. Cognitive impairment is a common complication of maintenance hemodialysis patients, and its specific mechanism is not yet clear. Type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) are independent risk factors for cognitive impairment. The prevalence of cognitive impairment is higher in patients with type 2 diabetes and advanced chronic kidney disease, especially in patients with diabetes and end-stage renal disease (ESKD). T2DM and ESKD independently increase the risk of cerebrovascular disease and cognitive impairment. However, the relationship between diabetes mellitus and cognitive function in maintenance hemodialysis patients is unclear. However, compared with the general population, patients with type 2 diabetes mellitus (T2DM) and patients with advanced chronic kidney disease (CKD) had more severe brain atrophy, and the severity of white matter lesions on brain MRI increased. To sum up, the study of cognitive dysfunction is very important in maintenance hemodialysis patients with diabetes. It is urgent for us to explore the changes of cognitive impairment and brain magnetic resonance in maintenance hemodialysis patients with diabetes, so as to help detect brain cell damage and improve the survival rate and quality of life in the early stage of the disease.

Conditions

Maintenance Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Brain magnetic resonance high-resolution structural imaging was performed to observe the changes of brain structure

  All participants were examined with 3.0T MRI scanner (GE Healthcare, discovery mr750w, Milwaukee, WI), using quantitative techniques such as high-resolution structural magnetic resonance, resting state functional magnetic resonance and arteriovenous spin labeling imaging (ASL).

  15 to 20 minutes

Secondary Outcomes (1)

• The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)

  10 minutes

Study Arms (2)

Maintenance hemodialysis with diabetes group

The patients were given a quiet environment and completed the test within 10 minutes. The cognitive function of the two groups of patients was evaluated and analyzed using the Montreal Cognitive Assessment Scale (MoCA) in Chinese. The patients were given brain magnetic resonance high resolution structural imaging to observe changes in brain structure.

Diagnostic Test: Chinese version of the Montreal Cognitive Assessment Scale (MoCA) and brain magnetic resonance high resolution structural imaging

Maintenance hemodialysis non diabetic group

The patients were given a quiet environment and completed the test within 10 minutes. The cognitive function of the two groups of patients was evaluated and analyzed using the Montreal Cognitive Assessment Scale (MoCA) in Chinese. The patients were given brain magnetic resonance high resolution structural imaging to observe changes in brain structure.

Diagnostic Test: Chinese version of the Montreal Cognitive Assessment Scale (MoCA) and brain magnetic resonance high resolution structural imaging

Interventions

Chinese version of the Montreal Cognitive Assessment Scale (MoCA) and brain magnetic resonance high resolution structural imaging DIAGNOSTIC_TEST

Chinese version of Montreal cognitive assessment scale and brain magnetic resonance high resolution structural imaging

Maintenance hemodialysis non diabetic group; Maintenance hemodialysis with diabetes group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During the period of 2023.01-2023.07 selection, 100 patients with complete and consistent data were collected from Beijing Friendship Hospital affiliated to Capital Medical University, Beijing Shunyi District hospital, and regular hemodialysis patients. According to whether they were diagnosed as diabetes, they were diabetic group and non-diabetic group respectively.

You may qualify if:

• Age must be greater than 18 years old
• Receiving primary or higher education
• Dialysis 3 times a week, 4 hours per session, with dialysis time greater than 3 months
• Voluntarily participate in this study and sign an informed consent form.

You may not qualify if:

• The patient has any known Nervous system disease, such as dementia or Parkinson's disease.
• Have a history of mental illness, such as depression or schizophrenia.
• Suffering from visual, hearing, and language impairments, unable to cooperate with cognitive function assessment
• In the past 3 months, he has been unconscious, unconscious or other stress states due to infection, acute cardio cerebral Vascular disease.
• Suffering from severe liver damage or other serious physical diseases that may affect cognitive function.
• Have Alcohol dependence or psychotropic substance abuse, and currently use drugs that affect cognitive function or renal function.
• Patients with metallic substances in their bodies cannot pass magnetic resonance imaging (MRI) examination.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Shuyi Hospital: collaborator

Study Sites (2)

Beijing Friendship hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Ethics Committee of Beijing Shunyi District Hosipital.

Beijing, Beijing Municipality, 101300, China

RECRUITING

Study Officials

• Jia Wang

  student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WenHu LIU

CONTACT

15011393263; wenhuliu@mail.ccmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 20, 2023
• Study Start: May 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)