NCT05654727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 8, 2022

Last Update Submit

December 16, 2022

Conditions

Diabetes Type 2PreDiabetesCognitive Impairment

Keywords

diabetesBDNFT2DMprediabetescognition

Outcome Measures

Primary Outcomes (2)

  • Cognitive Functions

    MoCA total score and subscores were used to evalaute cognitive functions

    baseline

  • BDNF

    Serum BDNF were evaluated by Elisa

    baseline

Study Arms (3)

Type 2 Diabetes Mellitus

Prediabetes

Healthy Control

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetes, prediabetes and control patients who applied to the internal medicine outpatient clinic of Bezmialem Vakıf University and met the inclusion/exclusion conditions of the study

You may qualify if:

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

You may not qualify if:

  • severe psychiatric (e.g,major depressive disorder) or neurologic disorder (demyelinating diseases, stroke or brain tumor)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateCognitive DysfunctionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

October 1, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations

TU(1)