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

Diabetes Mellitus Clinical Trial

— TEMD-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06347445
• Other study ID #: GSM012024
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2024
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5707
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• There is no intervention.
There is no intervention.

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Department of Endocrinology and Metabolism	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	7 days
Primary	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.	7 days
Primary	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.	7 days
Primary	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.	7 days