NCT05915884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

June 14, 2023

Last Update Submit

April 25, 2024

Conditions

Keywords

SGLT-2 inhibitortriglyceride index

Outcome Measures

Primary Outcomes (1)

  • Change in triglyceride index

    Decreased triglyceride index among patients using SGLT-2 inhibitors.

    3 months

Study Arms (1)

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

Interventions

This study is an observational study. It is not planned to do an interventional activity.

Type 2 diabetic patients using SGLT-2 inhibitors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a diagnosis of type 2 Diabetes Mellitus 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 above, the patients will be evaluated and the data of the patients admitted to the study will be analyzed.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Education and Research Hospital

Samsun, İlkadım, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic DiseasesDiabetes Mellitus

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • DÜRİYE SILA KARAGÖZ ÖZEN

    Samsun Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Internal Medicine Specialist

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

June 10, 2023

Primary Completion

October 28, 2023

Study Completion

January 28, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations