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NCT Number: NCT03503045

The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overtreatment for glycemia

    Time frame: 7 days

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

Secondary outcomes

  1. Undertreatment for glycemia

    Time frame: 7 days

    HbA1c>9%

  2. Overtreatment for blood pressure

    Time frame: 7 days

    systolic blood pressure < 120 mmHg or diastolic blood pressure < 65 mmHg and use of at least one drug additional to ACE inhibitors

  3. Undertreatment for blood pressure

    Time frame: 7 days

    SBP≥140 mmHg or DPB ≥ 90 mmHg and use of two or less drugs

  4. Deintensification of treatment

    Time frame: 7 days

    discontinuation or dosage decrease within 6 months after the index measurement.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2018
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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