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

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.

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 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 Type: Observational
• Enrollment (Actual): 5240

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06018
    • Gulhane School of Medicine Department of Endocrinology and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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:

• 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.

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 > 7%	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control status of Turkish adult patients with diabetes mellitus	Home blood pressure <135/85 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 < 100 mg/dl, 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 24, 2017
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular risk status; Optimal metabolic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: GSM012017

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