The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

The Rates of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503045
• Other study ID #: GSM-012018
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2019
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Diabetes mellitus is one of the most common chronic diseases which lead to serious public health problems and a significant economic burden worldwide. The prevalence of diabetes in elderly patients is very high and is predicted to increase dramatically.

Prior studies have generally been concerned with the inadequate treatment of diabetes however, over the last few years the overtreatment of diabetes has also come to the fore. Unfortunately, there are very few data worldwide and no data in Turkey about the overtreatment of patients with type 2 diabetes.

This study aimed to assess the rates and predictors of overtreatment and undertreatment of glycemia and blood pressure in older adults with T2DM. Treatment deintensification or intensification by the physicians were also investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1276
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Younger than 65 years old

• having decompensated liver disease

• psychiatric disorders interfering cognition or compliance

• having bariatric surgery or on renal replacement therapy

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine	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	Overtreatment for glycemia	HbA1c<6.5% plus use of =2 oral hypoglycemics or insulin, except metformine.	7 days
Secondary	Undertreatment for glycemia	HbA1c>9%	7 days
Secondary	Overtreatment for blood pressure	systolic blood pressure < 120 mmHg or diastolic blood pressure < 65 mmHg and use of at least one drug additional to ACE inhibitors	7 days
Secondary	Undertreatment for blood pressure	SBP=140 mmHg or DPB = 90 mmHg and use of two or less drugs	7 days
Secondary	Deintensification of treatment	discontinuation or dosage decrease within 6 months after the index measurement.	7 days