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CompletedNCT05915884Updated Apr 26, 2024

The Triglyceride/Glucose Index and SGLT-2 Inhibitors

An observational study in Metabolic Disease and Diabetes, sponsored by Samsun Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Samsun Education and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
55
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Disease
  • Diabetes

Keywords

  • SGLT-2 inhibitor
  • triglyceride index
03

In context

Metabolic Diseases

763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.

This study's enrollment of 55 is below the median of 200 across 211 observational studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Samsun Education and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Type 1 diabetes
  • Gestational diabetes
  • Age \< 18 years old
  • Insufficient or missed laboratory test results
  • Medical treatment for dyslipidemia
  • Hypothyroidism
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSGLT-2 inhibitors

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

06

What researchers measure

Primary outcomes

  1. Change in triglyceride index

    Decreased triglyceride index among patients using SGLT-2 inhibitors.

    Time frame: 3 months

07

Study locations

1 site
  • Samsun Education and Research Hospital
    Samsun, İlkadım 55200, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Oct 2023, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2023
First posted
Jun 23, 2023
StartActual
Jun 10, 2023
Primary completionActual
Oct 28, 2023
CompletionActual
Jan 28, 2024
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05915884
Lead sponsor
Samsun Education and Research Hospital
Responsible party
Duriye Sila Karagoz Ozen (MD,Internal Medicine Specialist, Samsun Education and Research Hospital) — Principal investigator
First posted
Jun 23, 2023
Start date
Jun 10, 2023
Primary completion
Oct 28, 2023
Completion
Jan 28, 2024
Last update
Apr 26, 2024

Study contacts

DÜRİYE SILA KARAGÖZ ÖZEN
principal investigator · Samsun Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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