The Impact of Frailty in Type 2 Diabetes

NCT05863611 | Unknown

• 1 other identifier: KirikkaleUniversity711
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frailty has an effect on the risk of falling in patients with type 2 diabetes.

  march 15, 2023 - june 10 , 2023

Study Arms (2)

25 individuals with frailty syndrome with type 2 diabetes

Other: arms

25 individuals without frailty syndrome with type 2 diabetes

Other: arms

Interventions

arms OTHER

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.

25 individuals with frailty syndrome with type 2 diabetes; 25 individuals without frailty syndrome with type 2 diabetes

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

be diagnosed with type 2 diabetes be over 65 years old

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Gulsah Turanoglu

Kırıkkale, Merkez, 71000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: May 18, 2023
• Study Start: May 20, 2023
• Primary Completion: May 25, 2023
• Study Completion: June 10, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: march 15,2023 - june 10,2023

Locations

TU (1)