NCT03503045

Brief Summary

This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,276

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
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

April 11, 2018

Last Update Submit

February 19, 2019

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusPolypharmacyOvertreatmentUndertreatment

Outcome Measures

Primary Outcomes (1)

  • Overtreatment for glycemia

    HbA1c\<6.5% plus use of ≥2 oral hypoglycemics or insulin, except metformine.

    7 days

Secondary Outcomes (4)

  • Undertreatment for glycemia

    7 days

  • Overtreatment for blood pressure

    7 days

  • Undertreatment for blood pressure

    7 days

  • Deintensification of treatment

    7 days

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 years and older and 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 Diabetes Mellitus type I or II
  • Age 65 years or older
  • To be under follow-up in the same center for at least one year.

You may not qualify if:

  • Younger than 65 years old
  • having decompensated liver disease
  • psychiatric disorders interfering cognition or compliance
  • having bariatric surgery or on renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alper Sonmez, Prof.Dr.

    Gulhane School of Medicine, Endocrinology and Metabolism

    STUDY DIRECTOR

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

April 11, 2018

First Posted

April 19, 2018

Study Start

April 1, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)