ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03455101
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine

Brief Summary:
This study evaluates the overall cardiovascular risk status and best predictors of optimal metabolic control of Turkish adult patients with diabetes mellitus.

Condition or disease Intervention/treatment
Diabetes Mellitus 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
Actual Enrollment : 5240 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus (TEMD Study)
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

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.




Primary Outcome Measures :
  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 > 7%


Secondary Outcome Measures :
  1. Blood pressure control status of Turkish adult patients with diabetes mellitus [ Time Frame: 7 days ]
    Home blood pressure <135/85 mmHg will be defined as under control.

  2. Lipid control status of Turkish adult patients with diabetes mellitus. [ Time Frame: 7 days. ]
    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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455101


Locations
Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine

Responsible Party: Alper Sonmez, Prof. Dr., Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT03455101     History of Changes
Other Study ID Numbers: GSM012017
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alper Sonmez, Gulhane School of Medicine:
Cardiovascular risk status
Optimal metabolic control

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases