Type 2 Diabetes MellitusNCT05863611
The Impact of Frailty in Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- arms
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 10 Jun 2023
- 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
- Healthy volunteers accepted
- Older adult
Study population: be diagnosed with type 2 diabetes be over 65 years old
Who may be able to join
- Diagnosed with diabetes
- Being 65 years or older
- Not having a cooperation problem,
- No communication difficulties or problems voluntarily accepting participation in the research
Who cannot join
- - Those with uncontrollable hypertension, heart disease, cardiac arrhythmia
- Those with cardiovascular disease
- Those who have malignancy and cause malignancy, chemotherapy, radiotherapy
- Those with any neurological or orthopedic disorders
- Those who have had an operation in the last 6 months
- Those on bed rest
- Individuals addicted to alcohol and drugs
- Those who do not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Frailty on Balance and Fall Risk in Patients With Type 2 Diabetes
The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in which participants demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale and balance assessment will be made with the Tinetti Balance. participants will not need to spend a long time for all assessments. The time required for the assessment will be around 30 minutes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- arms
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
armsOther
During the research, a questionnaire form (age, gender, educational status, etc.) in which your demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale. Balance assessment will be made with the Tinetti Balance and Gait Assessment.
| Study group | Role | What they receive |
|---|---|---|
| 25 individuals with frailty syndrome with type 2 diabetes | Not described Receives: Other: arms | |
| 25 individuals without frailty syndrome with type 2 diabetes | Not described Receives: Other: arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty has an effect on balance in patients with type 2 diabetes.
Balance assessment will be made with the Tinetti Balance
Measured: march 15, 2023 - june 10 , 2023
Secondary outcomes (1)
Frailty has an effect on the risk of falling in patients with type 2 diabetes.
Fall assessment will be assessed with the Fall Risk Self-Assessment Scale
Measured: march 15, 2023 - june 10 , 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start20 May 2023 (estimated)
- Primary completion25 May 2023 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Turanoglu, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863611
- Sponsor's protocol ID
- KirikkaleUniversity711
- Status last verified
- May 2023
- First submitted
- 11 Jan 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frailty on Balance and Fall Risk in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05863611
- Acronym / sponsor ID
- KirikkaleUniversity711
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 25 May 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 18 May 2023 (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.
The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in which participants demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale and balance assessment will be made with the Tinetti Balance. participants will not need to spend a long time for all assessments. The time required for the assessment will be around 30 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 individuals with frailty syndrome with type 2 diabetes | – | Other: arms |
| 25 individuals without frailty syndrome with type 2 diabetes | – | Other: arms |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- be diagnosed with type 2 diabetes be over 65 years old
Key inclusion criteria (4 listed)
- Diagnosed with diabetes
- Being 65 years or older
- Not having a cooperation problem,
- No communication difficulties or problems voluntarily accepting participation in the research
Key exclusion criteria (8 listed)
- - Those with uncontrollable hypertension, heart disease, cardiac arrhythmia
- Those with cardiovascular disease
- Those who have malignancy and cause malignancy, chemotherapy, radiotherapy
- Those with any neurological or orthopedic disorders
- Those who have had an operation in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| armsDuring the research, a questionnaire form (age, gender, educational status, etc.) in which your demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale. Balance assessment will be made with the Tinetti Balance and Gait Assessment. | Other | 25 individuals with frailty syndrome with type 2 diabetes, 25 individuals without frailty syndrome with type 2 diabetes |
Primary outcome
Frailty has an effect on balance in patients with type 2 diabetes.
Time frame: march 15, 2023 - june 10 , 2023
Balance assessment will be made with the Tinetti Balance
1 secondary outcome
Frailty has an effect on the risk of falling in patients with type 2 diabetes.
Time frame: march 15, 2023 - june 10 , 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 Diabetes Mellitus, run by Kırıkkale University 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 May 2023. 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?
Results are not available in the source record.
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?
Frailty has an effect on balance in patients with type 2 diabetes. (time frame: march 15, 2023 - june 10 , 2023). 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 18 May 2023.