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Enrolling by invitationNCT05863611Updated May 18, 2023

The Impact of Frailty in Type 2 Diabetes

An observational study in Type 2 Diabetes Mellitus, sponsored by Kırıkkale University. Enrolling by invitation at 1 site in Turkey. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-18.

Sponsored by Kırıkkale University · Observational

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 4 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 50 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Kırıkkale University is the lead sponsor of 112 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

be diagnosed with type 2 diabetes be over 65 years old

Inclusion criteria

  • Diagnosed with diabetes
  • Being 65 years or older
  • Not having a cooperation problem,
  • No communication difficulties or problems voluntarily accepting participation in the research

Exclusion criteria

Exclusion Criteria:

    • 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 25 individuals with frailty syndrome with type 2 diabetes

    Other: arms

  • 25 individuals without frailty syndrome with type 2 diabetes

    Other: arms

Interventions

  • Otherarms

    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.

06

What researchers measure

Primary outcomes

  1. Frailty has an effect on balance in patients with type 2 diabetes.

    Balance assessment will be made with the Tinetti Balance

    Time frame: 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

    Time frame: march 15, 2023 - june 10 , 2023

07

Study locations

1 site
  • Gulsah Turanoglu
    Kırıkkale, Merkez 71000, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05863611
Lead sponsor
Kırıkkale University
Responsible party
Gulsah Turanoglu (Principal Investigator, Kırıkkale University) — Principal investigator
First posted
May 18, 2023
Start date
May 20, 2023 (estimated)
Primary completion
May 25, 2023 (estimated)
Completion
Jun 10, 2023 (estimated)
Last update
May 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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