Cognitive Functions and BDNF in T2DM and Prediabetes Patients

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Completed

CT.gov ID

NCT05654727

Collaborator

(none)

230

Enrollment

Location

Actual Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Type 2 PreDiabetes Cognitive Impairment

Detailed Description

Cognitive dysfunction is increasingly recognized as a common complication and comorbidity in both type 1 and type 2 diabetes (T2DM). Due to the increasing incidence of diabetes and the life expectancy of individuals with T2DM, it is important to determine the cognitive problems and related factors in these patients. Cognitive impairment can be observed in all age groups in individuals with diabetes, and its severity can range from mild cognitive impairment to dementia. Although there are few studies in the literature investigating cognitive impairment in prediabetes, it is not clear whether it is a risk factor.

The number of studies investigating biomarkers of potential importance for understanding changes in the brain of T2DM patients is increasing rapidly. The relationship of biomarkers associated with the main pathologies of dementia, including Alzheimer's disease (AD) and vascular disease, as well as various biomarkers associated with brain parenchymal damage, blood flow and metabolism, with the cognitive status of diabetic patients are investigated. It has been determined in animal experiments that Brain Induced Neurotrophic Factor (BDNF) may be among the molecular factors linking T2DM with dementia neuropathology. It has also been stated that high glucose levels are associated with cognitive impairment and total hippocampal volume reductions, and hippocampal changes can be used as an early marker of diabetes-related brain damage. Considering that the expression of BDNF in the brain is high in hippocampus neurons, it may be an early marker of cognitive impairment in diabetes.

This research is a cross-sectional observational study. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.

Study Design

Study Type:

Observational

Actual Enrollment :

230 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Cognitive Impairment and BDNF in Patients With Diabetes and Prediabetes

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Type 2 Diabetes Mellitus
Prediabetes
Healthy Control

Outcome Measures

Primary Outcome Measures

Cognitive Functions [baseline]
MoCA total score and subscores were used to evalaute cognitive functions
BDNF [baseline]
Serum BDNF were evaluated by Elisa

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age from 30 to 65 years
having at least primary school education

Exclusion Criteria:

severe psychiatric (e.g,major depressive disorder) or neurologic disorder (demyelinating diseases, stroke or brain tumor)
using insulin (Insulin therapy was taken as an exclusion criterion to avoid the effect of hypoglycemia on cognition)
vision and hearing problem
Hypothyroidism, B12 and folic acid deficiency
Advanced chronic renal failure (stage 4-5)
uncontrolled hypertension
patients with hypoglycemia-hyperglycemia attacks
Alcohol, substance addiction.