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NCT Number: NCT06347445

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

This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey.

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Key information

Conditions

Diabetes Mellitus Behavior Behavioral Symptoms Depression Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Signs and Symptoms Sleep Wake Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

There is no intervention.

Other

There is no intervention.

Primary outcomes

  1. 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%

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Acronym: TEMD-2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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