Increased brain iron deposition in type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN20008650
• Lead Sponsor: Shandong Provincial Hospital Affiliated to Shandong First Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-30
• Study Start: 2023-11-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 535

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.

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured at baseline and 3 months:<br> 1. Cognitive ability is measured using the Beijing version of the Montreal Cognitive Assessment (MoCA)<br> 2. The presence and severity of diabetic peripheral sensorimotor polyneuropathy is measured using The Toronto Clinical Scoring System (TCSS)<br> 3. Depression and anxiety is measured using Hospital Anxiety and Depression Scale (HADS)<br> 4. Movements, the individual’s risk of falls and other adverse consequences is measured using the Timed Up and Go (TUG) test and Gait speed<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured by self report or by blood test at baseline and 3 months:<br> 1. Age (years)<br> 2. Gender<br> 3. Height (m), weight (kg), body mass index (kg/m2)<br> 4. HbA1c<br> 5. Hypertension<br> 6. Diabetes<br> 7. Hyperlipidemia<br> 8. Total cholesterin (mmol/l)<br> 9. Triglyceride (mmol/l)<br> 10. High density lipoprotein (mmol/l)<br> 11. Low density lipoprotein (mmol/l)<br> 12. Smoking and drinking<br> 13. Education (year)<br> 14. Total-tau (mmol/l)<br> 15. Aß1-42 (mmol/l)<br> 16. P-Tau-181<br> 17. APOE<br>