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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455101
Other study ID # GSM012017
Secondary ID
Status Completed
Phase N/A
First received September 24, 2017
Last updated February 27, 2018
Start date April 1, 2017
Est. completion date June 30, 2017

Study information

Verified date February 2018
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 5240
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
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:

- 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 Design


Related Conditions & MeSH terms


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 > 7% 7 days
Secondary 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
Secondary 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.
Secondary 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.
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