The Triglyceride/Glucose Index and SGLT-2 Inhibitors

Sponsor
Samsun Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05915884
Collaborator
(none)
100
1
2.7
36.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SGLT-2 inhibitors

Detailed Description

Purpose: 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.

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.

Inclusion Criteria:

Being diagnosed with type 2 DM be over 18 years old Using an SGLT-2 inhibitor (dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg) To be followed in our hospital for at least 3 months

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Investigation of the Triglyceride/Glucose Index in Diabetic Patients Using SGLT-2 Inhibitor
Actual Study Start Date :
Jun 10, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Type 2 diabetic patients using 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.

Other: SGLT-2 inhibitors
This study is an observational study. It is not planned to do an interventional activity.

Outcome Measures

Primary Outcome Measures

  1. Change in triglyceride index [3 months]

    Decreased triglyceride index among patients using SGLT-2 inhibitors.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Being diagnosed with type 2 DM be over 18 years old Using an SGLT-2 inhibitor (dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg) To be followed in our hospital for at least 3 months

Exclusion Criteria:

Having type 1 diabetes or gestational diabetes be under the age of 18 Being followed up in our hospital for less than 3 months Lack of triglyceride, glucose, and glycosylated hemoglobin values at the beginning of the treatment and at the 3rd month of control Patient receiving medical treatment with a diagnosis of dyslipidemia Being diagnosed with hypothyroidism Initiation of additional antidiabetic drugs other than SGLT 2 inhibitor in the same period

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsun Education and Research Hospital Samsun İlkadım Turkey 55200

Sponsors and Collaborators

  • Samsun Education and Research Hospital

Investigators

  • Principal Investigator: DÜRİYE SILA KARAGÖZ ÖZEN, Samsun Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duriye Sila Karagoz Ozen, MD,Internal Medicine Specialist, Samsun Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05915884
Other Study ID Numbers:
  • 1
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duriye Sila Karagoz Ozen, MD,Internal Medicine Specialist, Samsun Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2023