Metabolic DiseaseNCT05915884
The Triglyceride/Glucose Index and SGLT-2 Inhibitors
An observational study of Metabolic Disease and Diabetes, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Disease, Diabetes
- What is being tested?
- SGLT-2 inhibitors
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2023to 28 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Type 2 DM
- Age >18 years old
- Dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg
- 3 months follow-up period
Who cannot join
- Type 1 diabetes
- Gestational diabetes
- Age < 18 years old
- Insufficient or missed laboratory test results
- Medical treatment for dyslipidemia
- Hypothyroidism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Education and Research Hospital
Samsun, İlkadım, 55200
About this study
Official title: Investigation of the Triglyceride/Glucose Index in Diabetic Patients Using SGLT-2 Inhibitor
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.
- Conditions
- Metabolic Disease, Diabetes
- Being tested
- SGLT-2 inhibitors
- Keywords
- SGLT-2 inhibitor, triglyceride index
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorsOther
This study is an observational study. It is not planned to do an interventional activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SGLT-2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in triglyceride index
Decreased triglyceride index among patients using SGLT-2 inhibitors.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start10 Jun 2023
- Primary completion28 Oct 2023
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duriye Sila Karagoz Ozen, Samsun Education and Research Hospital
- Investigators
- DÜRİYE SILA KARAGÖZ ÖZEN, Principal investigator, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915884
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Triglyceride/Glucose Index in Diabetic Patients Using SGLT-2 Inhibitor
- ClinicalTrials.gov ID
- NCT05915884
- Acronym / sponsor ID
- 1
- Conditions
- Metabolic Disease, Diabetes
- Keywords
- SGLT-2 inhibitor, triglyceride index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients using SGLT-2 inhibitors | – | Other: SGLT-2 inhibitorsThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Type 2 DM
- Age >18 years old
- Dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg
- 3 months follow-up period
Key exclusion criteria (6 listed)
- Type 1 diabetes
- Gestational diabetes
- Age < 18 years old
- Insufficient or missed laboratory test results
- Medical treatment for dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitorsThis study is an observational study. It is not planned to do an interventional activity. | Other | Type 2 diabetic patients using SGLT-2 inhibitors |
Primary outcome
Change in triglyceride index
Time frame: 3 months
Decreased triglyceride index among patients using SGLT-2 inhibitors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DÜRİYE SILA KARAGÖZ ÖZEN principal investigator
Samsun Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Diabetes, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in triglyceride index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.