Diabetes MellitusTEMD-2NCT06347445
Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study)
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 5,707 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jan 2023
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 1 or type 2 diabetes who were under follow-up in the same tertiary endocrine unit for at least a year were enrolled.
Who may be able to join
- Patients with type 1 or type 2 diabetes
- Upper than 18 years old
- To be under follow-up in the same center for at least one year.
Who cannot join
- Pregnant or lactation period
- Younger than 18 years old
- History of psychiatric disorders interfering cognition or compliance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, 06010
About this study
This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey.
Read the detailed description
Diabetes mellitus is one of the most common chronic diseases worldwide.The prevalence of diabetes is increased significantly in Türkiye, from 7.2 % in 2002 to 13.7% in 2012. This increasing prevalence leads to serious public health problems and a significant economic burden. Many important diseases such as hypertension and dyslipidemia accompany the picture in diabetic patients. The optimal treatment of diabetes and prevention of diabetic complications, especially the cardiovascular outcomes, is utmost important. Although achieving glycemic targets in patients with diabetes is of great importance, blood glucose is not the only predictor of cardiovascular outcome in diabetes. Optimization of other metabolic parameters such as lipids, arterial blood pressure (ABP), and body weight as well as a healthy lifestyle are utmost important.
Common problems in diabetic patients, such as sleep disorders and sexual dysfunction, affect glycemia regulation in these patients.There is little data on the frequency of these diseases in diabetic patients in Türkiye.
In the TEMD-1 study conducted in 2017, the rates of diabetic patients achieving metabolic goals and the factors affecting these rates were revealed in Turkish patients with diabetes. The findings obtained in the current study will be compared with the findings in 2017, and in addition, the frequency of comorbidities such as sleep disorder, sexual dysfunction, and depression will be tried to be revealed.
- Conditions
- Diabetes Mellitus
- Being tested
- There is no intervention.
- Keywords
- glycemic regulation, metabolic control, sleep disorder, sexual dysfunction, depression
- Medical subject headings
- Diabetes Mellitus, Sleep Wake Disorders, Sexual Dysfunction, Physiological, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes mellitus | Patients with type 1 or type 2 diabetes who were under follow-up in the same center for at least a year. Receives: Other: There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia control status of Turkish adult patients with diabetes mellitus
Glycemia control will be defined as good control if the mean HbA1c level of patients < 7% or poor control if the mean HbA1c level of patient between 7% and 9% and very poor control if the mean HbA1c level of patient > 9%
Measured: 7 days
Blood pressure control status of Turkish adult patients with diabetes mellitus
Home blood pressure <135/85 mmHg or office blood pressure <140/90 mmHg will be defined as under control.
Measured: 7 days
Lipid control status of Turkish adult patients with diabetes mellitus.
Triglyceride < 150 mg/dl, LDL-C <55 mg/dl, <70 mg/dl and < 100 mg/dl according to the cardiovascular risk status, HDL-C > 40 mg/dl for men, and HDL-C > 50 mg/dl for women will be defined as under control.
Measured: 7 days
Weight control status of Turkish adult patients with diabetes mellitus.
Body mass index < 30 kg/m2 will be defined as under control. Weight and height will be combined to report body mass index in kg/m2.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Oct 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 5,707 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cem haymana, Gulhane School of Medicine
- Investigators
- Alper Sonmez, Prof., Principal investigator, Ankara Guven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347445
- Sponsor's protocol ID
- GSM012024
- Acronym
- TEMD-2
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guler BY, Demirci I, Haymana C, Akbay E, Evren B, Dizdar OS, Demir O, Agbaht K, Tasci I, Ersoy C, Salman S, Bayram F, Satman I, Sonmez A; TEMD-2 Study Group. Clinically relevant depression in patients with type 1 and type 2 diabetes; a nationwide study (TEMD-2 depression). Endocrine. 2026 Sep 9;91(1):293. doi: 10.1007/s12020-026-04676-7.
PubMed 42714690Sonmez A, Haymana C, Demirci I, Cetinarslan B, Gonen MS, Akbas EM, Yalin GY, Avci U, Tasci I, Salman S, Ersoy C, Bayram F, Satman I; TEMD-2 Study Group. Turkish cross-sectional survEy of glycemic and other Metabolic parameters in patients with type 2 Diabetes in 2023: Comparison with 2018 nationwide data (TEMD-2 study). J Diabetes Complications. 2026 Sep;40(9):109348. doi: 10.1016/j.jdiacomp.2026.109348. Epub 2026 May 27.
PubMed 42413349Sah Unal FT, Gokcay Canpolat A, Emral R, Haymana C, Demirci I, Salman S, Ersoy C, Bayram F, Satman I, Sonmez A, Corapcioglu D, Temd-Study Group. Polypharmacy and associated factors in patients with type 2 diabetes: a nationwide cross-sectional study (TEMD-2 polypharmacy study). Postgrad Med. 2026 Jun;138(5):557-566. doi: 10.1080/00325481.2026.2673267. Epub 2026 May 13.
PubMed 42130190
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study)
- ClinicalTrials.gov ID
- NCT06347445
- Acronym / sponsor ID
- TEMD-2 / GSM012024
- Conditions
- Diabetes Mellitus
- Keywords
- glycemic regulation, metabolic control, sleep disorder, sexual dysfunction, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,707 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 4 Apr 2024 (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 evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey.
Detailed description
Diabetes mellitus is one of the most common chronic diseases worldwide.The prevalence of diabetes is increased significantly in Türkiye, from 7.2 % in 2002 to 13.7% in 2012. This increasing prevalence leads to serious public health problems and a significant economic burden. Many important diseases such as hypertension and dyslipidemia accompany the picture in diabetic patients. The optimal treatment of diabetes and prevention of diabetic complications, especially the cardiovascular outcomes, is utmost important. Although achieving glycemic targets in patients with diabetes is of great importance, blood glucose is not the only predictor of cardiovascular outcome in diabetes. Optimization of other metabolic parameters such as lipids, arterial blood pressure (ABP), and body weight as well as a healthy lifestyle are utmost important.
Common problems in diabetic patients, such as sleep disorders and sexual dysfunction, affect glycemia regulation in these patients.There is little data on the frequency of these diseases in diabetic patients in Türkiye.
In the TEMD-1 study conducted in 2017, the rates of diabetic patients achieving metabolic goals and the factors affecting these rates were revealed in Turkish patients with diabetes. The findings obtained in the current study will be compared with the findings in 2017, and in addition, the frequency of comorbidities such as sleep disorder, sexual dysfunction, and depression will be tried to be revealed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes mellitus | – | Other: There is no intervention.Patients with type 1 or type 2 diabetes who were under follow-up in the same center for at least a year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 or type 2 diabetes who were under follow-up in the same tertiary endocrine unit for at least a year were enrolled.
Key inclusion criteria (3 listed)
- Patients with type 1 or type 2 diabetes
- Upper than 18 years old
- To be under follow-up in the same center for at least one year.
Key exclusion criteria (3 listed)
- Pregnant or lactation period
- Younger than 18 years old
- History of psychiatric disorders interfering cognition or compliance
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 |
|---|---|---|
| There is no intervention.There is no intervention. | Other | Patients with diabetes mellitus |
Primary outcome
Glycemia control status of Turkish adult patients with diabetes mellitus
Time frame: 7 days
Glycemia control will be defined as good control if the mean HbA1c level of patients < 7% or poor control if the mean HbA1c level of patient between 7% and 9% and very poor control if the mean HbA1c level of patient > 9%
Blood pressure control status of Turkish adult patients with diabetes mellitus
Time frame: 7 days
Home blood pressure <135/85 mmHg or office blood pressure <140/90 mmHg will be defined as under control.
Lipid control status of Turkish adult patients with diabetes mellitus.
Time frame: 7 days
Triglyceride < 150 mg/dl, LDL-C <55 mg/dl, <70 mg/dl and < 100 mg/dl according to the cardiovascular risk status, HDL-C > 40 mg/dl for men, and HDL-C > 50 mg/dl for women will be defined as under control.
Weight control status of Turkish adult patients with diabetes mellitus.
Time frame: 7 days
Body mass index < 30 kg/m2 will be defined as under control. Weight and height will be combined to report body mass index in kg/m2.
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 4 Apr 2024.
- Derived from this study: PubMed 42714690Guler BY, Demirci I, Haymana C, Akbay E, Evren B, Dizdar OS, Demir O, Agbaht K, Tasci I, Ersoy C, Salman S, Bayram F, Satman I, Sonmez A; TEMD-2 Study Group. Clinically relevant depression in patients with type 1 and type 2 diabetes; a nationwide study (TEMD-2 depression). Endocrine. 2026 Sep 9;91(1):293. doi: 10.1007/s12020-026-04676-7.
- Derived from this study: PubMed 42413349Sonmez A, Haymana C, Demirci I, Cetinarslan B, Gonen MS, Akbas EM, Yalin GY, Avci U, Tasci I, Salman S, Ersoy C, Bayram F, Satman I; TEMD-2 Study Group. Turkish cross-sectional survEy of glycemic and other Metabolic parameters in patients with type 2 Diabetes in 2023: Comparison with 2018 nationwide data (TEMD-2 study). J Diabetes Complications. 2026 Sep;40(9):109348. doi: 10.1016/j.jdiacomp.2026.109348. Epub 2026 May 27.
- Derived from this study: PubMed 42130190Sah Unal FT, Gokcay Canpolat A, Emral R, Haymana C, Demirci I, Salman S, Ersoy C, Bayram F, Satman I, Sonmez A, Corapcioglu D, Temd-Study Group. Polypharmacy and associated factors in patients with type 2 diabetes: a nationwide cross-sectional study (TEMD-2 polypharmacy study). Postgrad Med. 2026 Jun;138(5):557-566. doi: 10.1080/00325481.2026.2673267. Epub 2026 May 13.
- Individual participant dataSharing planned: No
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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.
Alper Sonmez, Prof. principal investigator
Ankara Guven 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 Diabetes Mellitus, run by Gulhane School of Medicine 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 3 inclusion and 3 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 4 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?
Glycemia control status of Turkish adult patients with diabetes mellitus (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06347445, which also lists 3 linked publications.
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 4 Apr 2024.