The Effect of SGLT2 Inhibitors on Heart Rate Variability and BDNF Levels in Patients With Type 2 Diabetes

NCT05164523 | Completed DMC

• 1 other identifier: Heart Rate Variability-BDNF
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac autonomic neuropathy (CAN) in diabetic patients is an indicator of autonomic nervous system dysfunction and is an important marker for cardiovascular events. Very promising results have been obtained with SGLT2 inhibitors in both cardiac and renal outcomes. The aim is to examine the effects of SGLT2 inhibitor use on cardiac autonomic neuropathy, heart rate variability, sympathetic and parasympathetic nervous system parameters, and their relationship with BDNF levels, one of the neuroinflammatory markers.

Conditions

Type 2 Diabetes; Heart Rate Variability

Keywords

type 2 diabetes; SGLT2 inhibitors; heart rate variability; sympathic activity; parasympathetic activity

Outcome Measures

Primary Outcomes (2)

• Heart rate variability parameters

  The investigators will evaluate the effects of SGLT2 inhibitor use on heart rate variability derived from 24-hour rhythm Holter compared with other antidiabetic medications.

  Six months

• BDNF concentrations

  The investigators will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on BDNF levels in type 2 diabetic patients.

  Six months

Study Arms (2)

Patients with type 2 diabetes treated with SGLT2 inhibitors

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

Diagnostic Test: 24-hour rhythm Holter; Diagnostic Test: 36 item Short Form Survey (SF-36)

Patients with type 2 diabetes treated with other oral agents

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

Diagnostic Test: 24-hour rhythm Holter; Diagnostic Test: 36 item Short Form Survey (SF-36)

Interventions

24-hour rhythm Holter DIAGNOSTIC_TEST

Before starting their newly prescribed medication, the investigators will apply 24-hour rhythm Holter and repeat it at the end of the trial.

Patients with type 2 diabetes treated with SGLT2 inhibitors; Patients with type 2 diabetes treated with other oral agents

36 item Short Form Survey (SF-36) DIAGNOSTIC_TEST

Before starting their newly prescribed medication, the investigators will apply SF-36 survey and repeat it at the end of the trial.

Also known as: SF-36

Patients with type 2 diabetes treated with SGLT2 inhibitors; Patients with type 2 diabetes treated with other oral agents

Eligibility Criteria

• Age: 30 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 30 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
• using beta blocker or non-dihydropyridine group calcium antagonists
• diabetic autonomous neuropathy
• atrial fibrillation
• an acute coronary event within the last 3 months

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

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: December 20, 2021
• Study Start: March 1, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 30, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

TU (1)