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CompletedNCT06347445TEMD-2Updated Apr 4, 2024

Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study)

An observational study in Diabetes Mellitus, sponsored by Gulhane School of Medicine. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Gulhane School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
5,707
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • glycemic regulation
  • metabolic control
  • sleep disorder
  • sexual dysfunction
  • depression
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 5,707 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Gulhane School of Medicine is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactation period
  • Younger than 18 years old
  • History of psychiatric disorders interfering cognition or compliance
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
5,707 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: There is no intervention.

Interventions

  • OtherThere is no intervention.

    There is no intervention.

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: 7 days

  2. 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.

    Time frame: 7 days

  3. 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.

    Time frame: 7 days

  4. 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.

    Time frame: 7 days

07

Study locations

1 site
  • Gulhane School of Medicine Department of Endocrinology and Metabolism
    Ankara, 06010, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06347445
Lead sponsor
Gulhane School of Medicine
Responsible party
cem haymana (Associate Proffesor, Gulhane School of Medicine) — Principal investigator
First posted
Apr 4, 2024
Start date
Oct 1, 2022
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023
Last update
Apr 4, 2024

Study contacts

Alper Sonmez, Prof.
principal investigator · Ankara Guven Hospital

Oversight

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

Not currently enrolling

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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