Diabetes MellitusTEMDNCT03455101
Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the overall cardiovascular risk status and best predictors of optimal metabolic control of Turkish adult patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 5,240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 30 Jun 2017
- 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
- Pregnancy
- Younger than 18 years old,
- History of decompensated liver disease,
- History of psychiatric disorders interfering cognition or compliance
- History of bariatric surgery
- History of renal replacement therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, 06018
About this study
Official title: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus (TEMD Study)
This study evaluates the overall cardiovascular risk status and best predictors of optimal metabolic control of Turkish adult patients with diabetes mellitus.
Read the detailed description
Diabetes mellitus is one of the most common chronic diseases with an increasing prevalence worldwide.The prevalence of diabetes is also increased significantly in Turkey, from 7.2 % in 2002 to 13.7% in 2012.This increasing prevalence leads to serious public health problems and a significant economic burden. Therefore, 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. As there is hardly enough data about glycemic and other metabolic control parameters in Turkish adult patients with type 1 or type 2 diabetes, this nationwide survey was performed.
- Conditions
- Diabetes Mellitus
- Being tested
- There is no intervention.
- Keywords
- Cardiovascular risk status, Optimal metabolic control
- Medical subject headings
- Diabetes Mellitus
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 > 7%
Measured: 7 days
Secondary outcomes (3)
Blood pressure control status of Turkish adult patients with diabetes mellitus
Home blood pressure <135/85 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 < 100 mg/dl, 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 posted6 Mar 2018
- Study start1 Apr 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 5,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sonmez, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455101
- Sponsor's protocol ID
- GSM012017
- Acronym
- TEMD
- Status last verified
- Feb 2018
- First submitted
- 24 Sep 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonmez A, Tasci I, Demirci I, Haymana C, Barcin C, Aydin H, Cetinkalp S, Ozturk FY, Gul K, Sabuncu T, Satman I, Bayram F; TEMD Study Group. A Cross-Sectional Study of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Diabetes Mellitus: The TEMD Overtreatment Study. Diabetes Ther. 2020 May;11(5):1045-1059. doi: 10.1007/s13300-020-00779-0. Epub 2020 Feb 22.
PubMed 32088879
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. 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 (TEMD Study)
- ClinicalTrials.gov ID
- NCT03455101
- Acronym / sponsor ID
- TEMD / GSM012017
- Conditions
- Diabetes Mellitus
- Keywords
- Cardiovascular risk status, Optimal metabolic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,240 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Mar 2018 (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 overall cardiovascular risk status and best predictors of optimal metabolic control of Turkish adult patients with diabetes mellitus.
Detailed description
Diabetes mellitus is one of the most common chronic diseases with an increasing prevalence worldwide.The prevalence of diabetes is also increased significantly in Turkey, from 7.2 % in 2002 to 13.7% in 2012.This increasing prevalence leads to serious public health problems and a significant economic burden. Therefore, 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. As there is hardly enough data about glycemic and other metabolic control parameters in Turkish adult patients with type 1 or type 2 diabetes, this nationwide survey was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- 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 (6 listed)
- Pregnancy
- Younger than 18 years old,
- History of decompensated liver disease,
- History of psychiatric disorders interfering cognition or compliance
- History of bariatric surgery
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 > 7%
3 secondary outcomes
Blood pressure control status of Turkish adult patients with diabetes mellitus
Time frame: 7 days
Lipid control status of Turkish adult patients with diabetes mellitus.
Time frame: 7 days.
Weight control status of Turkish adult patients with diabetes mellitus.
Time frame: 7 days.
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 6 Mar 2018.
- Derived from this study: PubMed 32088879Sonmez A, Tasci I, Demirci I, Haymana C, Barcin C, Aydin H, Cetinkalp S, Ozturk FY, Gul K, Sabuncu T, Satman I, Bayram F; TEMD Study Group. A Cross-Sectional Study of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Diabetes Mellitus: The TEMD Overtreatment Study. Diabetes Ther. 2020 May;11(5):1045-1059. doi: 10.1007/s13300-020-00779-0. Epub 2020 Feb 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 6 Mar 2018. 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). 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 NCT03455101, which also lists 1 linked publication.
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 6 Mar 2018.