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OpenTrials
Completed

NCT Number: NCT05654727

Cognitive Functions and BDNF in T2DM and Prediabetes Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cognitive Functions

    Time frame: baseline

    MoCA total score and subscores were used to evalaute cognitive functions

  2. BDNF

    Time frame: baseline

    Serum BDNF were evaluated by Elisa

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Cognitive Impairment and BDNF in Patients With Diabetes and Prediabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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