Increased brain iron deposition in type 2 diabetes
| ISRCTN | ISRCTN20008650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20008650 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DC23-2069 |
| Sponsor | Shandong Provincial Hospital Affiliated to Shandong First Medical University |
| Funder | Shandong Provincial Hospital Affiliated to Shandong First Medical University |
- Submission date
- 04/11/2023
- Registration date
- 07/11/2023
- Last edited
- 07/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is believed to be connected to an issue with how your body manages iron, and how it stores excess iron. The part of the brain called the basal ganglia, which has a lot of iron, goes through changes in how it stores iron in people with type 2 diabetes. These changes can affect both motor skills and thinking abilities, but we're not completely sure how it all works yet.
We want to find out more about how the brain handles iron in the basal ganglia in people with type 2 diabetes who also have diabetic peripheral neuropathy (DPN). To do this, we'll use a technique called quantitative susceptibility mapping (QSM). We're also going to see if these changes in iron in the brain are connected to how well people with type 2 diabetes can move and think.
Who can participate?
Type 2 diabetes patients and healthy controls aged 40 - 70 years
What does the study involve?
Cognitive and motor assessments, blood biochemical tests, and brain QSM imaging.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Shandong Provincial Hospital Affiliated to Shandong First Medical University (China)
When is the study starting and how long is it expected to run for?
January 2021 to December 2022
Who is funding the study?
Shandong Provincial Hospital Affiliated to Shandong First Medical University (China)
Who is the main contact?
Lingfei Guo, glfsci@163.com
Contact information
Public, Scientific, Principal investigator
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan
250021
China
 ORCID ID |
0000-0002-4885-625X |
|---|---|
| Phone | +86 531-68776789 |
| guolingfei@sdfmu.edu.cn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational cross-sectional cohort study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Increased brain iron deposition in the basial ganglia is associated with cognitive and motor dysfunction in type 2 diabetes |
| Study acronym | T2DM |
| Study objectives | Brain iron deposition increased in type 2 diabetes. |
| Ethics approval(s) |
Approved 18/11/2019, Ethical Committee of the Institutional Review Board (IRB) of Shandong Institute of Medical Imaging (324 Jing-wu Road, Jinan, 250021, China; +86 531-68776789; kewaichu@126.com), ref: 2019-002 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | To explore the changing mode of brain iron metabolism in the basal ganglia in type 2 diabetes patients with diabetic peripheral neuropathy (DPN) using quantitative susceptibility mapping (QSM) and further to investigate whether these changes are associated with cognitive and motor function in type 2 diabetes patients. All subjects undergo cognitive and motor assessments, blood biochemical tests, and brain QSM imaging. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline and 3 months: |
| Key secondary outcome measure(s) |
Measured by self report or by blood test at baseline and 3 months: |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 800 |
| Total final enrolment | 535 |
| Key inclusion criteria | The inclusion criteria for all subjects are: 1. Age from 40 to 70 years old 2. Right-handedness Healthy controls: 1. No history of diabetes and glycated hemoglobin (HbA1c) level between 4 and 6% 2. No history of severe mental or neurologic diseases 3. No history of head trauma, surgery, or tumors 4. No alcohol or drug abuse. Patients: 1. All patients met the diagnostic criteria of type 2 diabetes of the 2023 American Diabetes Association, and the diagnosis of diabetic peripheral neuropathy conformed to the Toronto consensus criteria. 2. Diabetic peripheral neuropathy patients had at least one type of neuropathy characterized by numbness, prickling, and burning pain primarily in the extremities, and the signs included weakening or disappearance of ankle reflexes or symmetric decrease of distal sensory symmetry. |
| Key exclusion criteria | The exclusion criteria for all patients are: 1. History of brain trauma, surgery, or tumors 2. Acute complications of type 2 diabetes 3. Severe hypertension 4. History of severe cerebrovascular, neurological, or mental diseases 5. Alcohol or drug abuse 6. MRI contraindications |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Jinan
250021
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysedduring the current study will be available upon request from Lingfei Guo, glfsci@163.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/11/2023: Trial's existence confirmed by Ethical Committee of the Institutional Review Board (IRB) of Shandong Institute of Medical Imaging.
