The Triglyceride/Glucose Index and SGLT-2 Inhibitors

Completed

• Conditions: Metabolic Disease; Diabetes
• Interventions: Other: SGLT-2 inhibitors

• Registration Number: NCT05915884
• Lead Sponsor: Samsun Education and Research Hospital

Brief Summary

This study was designed to evaluate the change in triglyceride glucose index, one of the atherosclerotic markers, in patients with type 2 DM followed in the Internal Medicine Clinic of Samsun University, Samsun Training, and Research Hospital.

Methods: The data of the patients who were followed up for at least 3 months by making a retrospective file review will be recorded and analyzed. It is planned to start the study following the ethics committee's approval.

Detailed Description

The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine outpatient clinic for 12 months in 2022 and were started on SGLT-2 inhibitor will be examined. According to the inclusion and exclusion criteria stated below, the patients will be evaluated and the data of the patients admitted to the study will be analyzed. The triglyceride glucose index of the patients before starting the SGLT-2 injection and the trig/glucose index at the end of 3 months of treatment will be calculated by the researchers using the data in the system. No additional blood tests or laboratory analyses will be performed on the patients. Triglyceride, glucose, and glycosylated hemoglobin values were checked at the beginning of the treatment and at the 3rd-month follow-up.

Study Timeline

• Study Start: 2023-06-10
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Primary Completion: 2023-10-28
• Study Completion: 2024-01-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Type 2 DM
• Age >18 years old
• Dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg
• 3 months follow-up period

Exclusion Criteria

• Type 1 diabetes
• Gestational diabetes
• Age < 18 years old
• Insufficient or missed laboratory test results
• Medical treatment for dyslipidemia
• Hypothyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetic patients using SGLT-2 inhibitors	SGLT-2 inhibitors	The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine outpatient clinic for 12 months in 2022 and were started on SGLT-2 inhibitor will be examined. According to the inclusion and exclusion criteria, the patients will be evaluated and the data of the patients admitted to the study will be analyzed. The triglyceride glucose index of the patients before starting the SGLT-2 treatment and the triglyceride glucose index at the end of 3 months of treatment will be calculated by the researchers using the data in the system. No additional blood tests or laboratory analyses will be performed on the patients.

Primary Outcome Measures

Name	Time	Method
Change in triglyceride index	3 months	Decreased triglyceride index among patients using SGLT-2 inhibitors.

Trial Locations

Locations (1)

Samsun Education and Research Hospital; 🇹🇷 Samsun, İlkadım, Turkey