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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: There is no intervention.

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 Type: Observational
• Enrollment (Actual): 5707

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; There is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine
• Investigators: Principal Investigator: Alper Sonmez, Prof., Ankara Güven Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: depression; metabolic control; sleep disorder; sexual dysfunction; glycemic regulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: GSM012024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No