Hydroxyl Free Radical Associated Effects of SGLT-2 Inhibitors in Type 2 Diabetes

NCT06797115 | Completed

• 1 other identifier: 641936355
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Beyond their metabolic effect, SGLT-2 inhibitors reduce the risk of heart failure and have cardiovascular and nephroprotective effects, yet their exact mechanism of action remains unclear. This prospective study included 40 patients with type 2 diabetes whose physician initiated SGLT-2 inhibitor therapy. Prior to and after 4 weeks of the initiation of use of SGLT-2 inhibitors, in addition to routine clinical and laboratory measurements, hydroxyl free radical and neuropathic evaluations were performed.

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• CPT

  current perception thresholds (CPT) at three frequencies (2000 Hz, 250 Hz, and 5 Hz) on both median and peroneal nerve, providing insight into large myelinated (2000Hz Aβ), medium-size myelinated (250Hz Aδ) and unmyelinated (5Hz C) small fibers function

  baseline and week 4

Secondary Outcomes (15)

• Fructosamine

  baseline and week 4

• Fasting plasma glucose

  baseline and week 4

• BMI

  baseline and week 4

• SBP (standing)

  baseline and week 4

• eGFR

  baseline and week 4

Interventions

SGLT-2 inhibitor DRUG

T2D patients for whom, in addition to administering any existing antidiabetic regimen, the treating physician decided to initiate SGLT-2 inhibitor therapy (empagliflozin or dapagliflozin) based on standard clinical indications.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients (19 male/21 female) undergoing 4 weeks of SGLT-2 inhibitor therapy (22 empagliflozin/18 dapagliflozin)

You may qualify if:

• T2D patients
• HbA1c\<10%
• eGFR\>30ml/min/1.73 m2

You may not qualify if:

• neuropathies of non-diabetic etiology (i.e., hereditary, drug- or toxin-induced, untreated hypothyroidism, folate deficiency (below 3.9 µg/L), vitamin B12 deficiency (below 200 ng/L),
• advanced hepatic- or renal disease,
• autoimmune disease,
• malignancy,
• regular excessive alcohol consumption (more than two units in men and more than one unit per day in women - one unit being defined as 15 g of pure alcohol)
• severe peripheral arterial disease, history of foot ulceration
• recurrent genital infections

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

2nd Department of Medicine and Nephrology-Diabetes Center, University of Pécs Medical School

Pécs, Baranya, H-7624, Hungary

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: July 18, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

HU (1)