The Effect of SGLT2 Inhibitors on Cognitive Functions and BDNF Levels in Patients With Type 2 Diabetes

NCT05341388 | Terminated DMC

• 1 other identifier: Cognitive-BDNF
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment is a common complication in diabetes for various reasons. Although glycemic control improves cognitive impairment, different antidiabetic medications' effects on cognitive functions are still being investigated. Brain-derived neurotrophic factor (BDNF) is a neuroinflammatory marker and a member of the neurotrophin family with growth factor properties. BDNF levels have been shown to decrease in mild cognitive dysfunction or in late-onset Alzheimer's disease. Our aim is to examine the effect of SGLT2 inhibitor use on cognitive functions and BDNF levels.

Conditions

Type2 Diabetes; Cognitive Impairment

Keywords

type 2 diabetes; cognitive impairment; BDNF; SGLT2 inhibitors

Outcome Measures

Primary Outcomes (2)

• Cognitive functions

  We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on cognitive functions in type 2 diabetic patients using Montreal Cognitive Assessment (MOCA) test

  Six months

• BDNF concentrations

  We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on BDNF levels in type 2 diabetic patients. We will also assess whether there is an association between cognitive functions and BDNF concentrations in these prespecified groups of patients.

  Six months

Secondary Outcomes (1)

• 36 item Short Form Survey (SF-36)

  Six months

Study Arms (2)

Patients with type 2 diabetes-SGLT2 inh

patients with type 2 diabetes who were recently prescribed an SGLT2 inhibitor

Diagnostic Test: MOCA cognitive evaluation test; Diagnostic Test: BDNF levels; Other: SF-36 test; Diagnostic Test: Geriatric depression test

Patients with type 2 diabetes-control

patients with type 2 diabetes who were recently prescribed a pre-defined antidiabetic medication other than SGLT2 inhibitors

Diagnostic Test: MOCA cognitive evaluation test; Diagnostic Test: BDNF levels; Other: SF-36 test; Diagnostic Test: Geriatric depression test

Interventions

MOCA cognitive evaluation test DIAGNOSTIC_TEST

Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.

Patients with type 2 diabetes-SGLT2 inh; Patients with type 2 diabetes-control

BDNF levels DIAGNOSTIC_TEST

Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.

Patients with type 2 diabetes-SGLT2 inh; Patients with type 2 diabetes-control

SF-36 test OTHER

Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.

Patients with type 2 diabetes-SGLT2 inh; Patients with type 2 diabetes-control

Geriatric depression test DIAGNOSTIC_TEST

Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.

Patients with type 2 diabetes-SGLT2 inh; Patients with type 2 diabetes-control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who refer to a diabetes outpatients clinics to an university hospital

You may qualify if:

• giving consent
• being 60 years old or older
• HbA1c concentrations between 6.5% and 8%
• using metformin as a single agent for at least 3 months
• diabetes age \<10 years

You may not qualify if:

• having uncontrolled hypothyroidism, hyperthyroidism, or other diseases that may affect cognitive functions
• ketoacidosis or coma
• cerebrovascular disease or psychiatric disorder
• mental retardation, psychosis, dementia, brain trauma, epilepsy and other cerebral diseases
• alcohol or other substance abuse
• hearing loss
• Presence of diseases that will affect cognitive function such as chronic inflammatory diseases and respiratory system diseases
• chronic kidney failure (GFR \<45)
• sleep apnea syndrome
• malignancy
• using a sulfonylurea or glinide

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ayse N Erbakan, MD

  Istanbul Medeniyet University Goztepe Research and TRaining Hospital

  PRINCIPAL INVESTIGATOR

• Mehmet Sargın, Prof

  Istanbul Medeniyet University

  STUDY CHAIR

• Nazmiye Özbilgin, Prof

  University of Health Sciences Siyami Ersek TCS Training and Research Hospital

  STUDY CHAIR

• Aytekin Oğuz, Prof

  Istanbul Medeniyet University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: April 22, 2022
• Study Start: March 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

TU (1)