NCT03455101

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 6, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

September 24, 2017

Last Update Submit

February 27, 2018

Conditions

Keywords

Cardiovascular risk statusOptimal metabolic control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Blood pressure control status of Turkish adult patients with diabetes mellitus

    7 days

  • Lipid control status of Turkish adult patients with diabetes mellitus.

    7 days.

  • Weight control status of Turkish adult patients with diabetes mellitus.

    7 days.

Study Arms (1)

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.

Interventions

There is no intervention.

Patients with diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 24, 2017

First Posted

March 6, 2018

Study Start

April 1, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

March 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations