How body weight relates to activity, function, balance, and quality of life in people with type 2 diabetes
The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
This project will see if body weight affects how active you are, how well you walk and balance, and your quality of life if you have type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07152509 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling 50 adults with type 2 diabetes at Bezmialem Vakıf University in Istanbul. Participants will complete face-to-face assessments including body composition (Omron), waist-to-hip ratio, lower extremity and grip strength (hand-held dynamometers), the International Physical Activity Questionnaire–Short Form, the 6-Minute Walk Test, Biodex balance testing, the Berg Balance Scale, and the Nottingham Health Profile for quality of life. No interventions are given; the study will analyze relationships between body weight/BMI and physical activity, functional capacity, balance, and quality of life. Data will be analyzed using IBM SPSS Statistics 20 to identify associations across the measured domains.
Who should consider this trial
Good fit: Adults aged 18–65 with a diagnosis of type 2 diabetes for at least one year, HbA1c between 6.5% and 11% at diagnosis, who can walk independently and have no major cognitive, neurologic, cardiopulmonary, renal, vestibular, or musculoskeletal conditions are ideal candidates.
Not a fit: People with uncontrolled cardiovascular or pulmonary disease, recent stroke or myocardial infarction, diabetic neuropathy or ulcers, chronic renal failure, major musculoskeletal problems, pregnancy, or serious sensory or cognitive impairments are unlikely to benefit from participation and are excluded.
Why it matters
Potential benefit: If findings show clear links, they could help clinicians target weight-related factors to improve activity, function, balance, and quality of life for people with type 2 diabetes.
How similar studies have performed: Previous observational studies have reported links between higher body weight and reduced physical function in type 2 diabetes, though methods and measures of balance and quality of life have varied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year * Being between 18 and 65 years of age * Having an HbA1c value between 6.5% and 11% at the time of diagnosis * No cognitive or mental problems * Ability to walk independently * Willingness to participate in the study Exclusion Criteria: * Presence of uncontrolled cardiovascular and pulmonary disease * Presence of vertigo or various vestibular system disorders * Presence of severe neurological or respiratory disease * History of stroke or myocardial infarction * Presence of a major musculoskeletal problem * Presence of chronic renal failure * Presence of diabetic ulcer or neuropathy * Pregnancy * Presence of hemolytic or renal anemia * Presence of serious visual, hearing, or speech impairments leading to lack of cooperation
Where this trial is running
Istanbul
- Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: SEMİRAMİS ÖZYILMAZ, Assoc. Prof. — Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation
- Study coordinator: ŞULE TOPÇU ŞAHİN, PhD (c)
- Email: fztsuletopcu@gmail.com
- Phone: +90 5398566970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.