The Impact of Frailty in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Frailty on Balance and Fall Risk in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05863611
• Other study ID #: KirikkaleUniversity711
• Status: Enrolling by invitation
• Start date: May 20, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: May 2023
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 10, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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:

• - 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Frailty
• Type 2 Diabetes Mellitus

Intervention

Other:
• arms
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.

Locations

Country	Name	City	State
Turkey	Gulsah Turanoglu	Kirikkale	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty has an effect on balance in patients with type 2 diabetes.	Balance assessment will be made with the Tinetti Balance	march 15, 2023 - june 10 , 2023
Secondary	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	march 15, 2023 - june 10 , 2023