Diabetes MellitusNCT03503045
The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,276 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Younger than 65 years old
- having decompensated liver disease
- psychiatric disorders interfering cognition or compliance
- having bariatric surgery or on renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Rates of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications 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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Polypharmacy, Overtreatment, Undertreatment
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Overtreatment for glycemia
HbA1c<6.5% plus use of ≥2 oral hypoglycemics or insulin, except metformine.
Measured: 7 days
Secondary outcomes (4)
Undertreatment for glycemia
HbA1c>9%
Measured: 7 days
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
Measured: 7 days
Undertreatment for blood pressure
SBP≥140 mmHg or DPB ≥ 90 mmHg and use of two or less drugs
Measured: 7 days
Deintensification of treatment
discontinuation or dosage decrease within 6 months after the index measurement.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Apr 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sonmez, Gulhane School of Medicine
- Investigators
- Alper Sonmez, Prof.Dr., Study director, Gulhane School of Medicine, Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503045
- Sponsor's protocol ID
- GSM-012018
- Status last verified
- Feb 2019
- First submitted
- 11 Apr 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rates of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03503045
- Acronym / sponsor ID
- GSM-012018
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Polypharmacy, Overtreatment, Undertreatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Younger than 65 years old
- having decompensated liver disease
- psychiatric disorders interfering cognition or compliance
- having bariatric surgery or on renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overtreatment for glycemia
Time frame: 7 days
HbA1c<6.5% plus use of ≥2 oral hypoglycemics or insulin, except metformine.
4 secondary outcomes
Undertreatment for glycemia
Time frame: 7 days
Overtreatment for blood pressure
Time frame: 7 days
Undertreatment for blood pressure
Time frame: 7 days
Deintensification of treatment
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Sonmez, Prof.Dr. study director
Gulhane School of Medicine, Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overtreatment for glycemia (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.