The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
NCT ID: NCT07152509
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-08-15
2025-10-15
Brief Summary
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Participants will be prospectively evaluated through face-to-face interviews. Assessments will include body composition analysis (Omron Body Composition Monitor), waist-to-hip ratio, lower extremity muscle strength (Muscle Hand-Held Dynamometer), grip strength (Hand Grip Dynamometer), physical activity level (International Physical Activity Questionnaire-Short Form), functional capacity (6-Minute Walk Test), balance (Biodex Balance System), clinical balance (Berg Balance Scale), and quality of life (Nottingham Health Profile).
All statistical analyses will be performed using IBM SPSS Statistics 20. With this study, we aim to comprehensively evaluate multiple parameters in individuals with T2DM and investigate their interrelationships, thereby contributing to the current body of knowledge in the literature.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Type 2 Diabetes Mellitus Group
Participants diagnosed with type 2 diabetes mellitus will be included. Participants will undergo comprehensive assessment including body composition, muscle strength, hand grip strength, physical activity level, functional capacity, balance, and quality of life. No interventional procedure will be applied; the study is observational and cross-sectional.
Observational Assessment
The demographic, clinical, and personal characteristics of the individuals will be collected and recorded through a questionnaire. For all participants, body fat percentage (%), skeletal muscle mass percentage (%), visceral fat percentage (%), and resting metabolic rate (kcal), measured using the Omron Body Composition Monitor, will be recorded. Waist and hip circumference will be measured with a tape measure; lower extremity muscle strength (M. Quadriceps) will be assessed with a muscle hand-held dynamometer; grip strength will be assessed with a hand grip dynamometer; physical activity level will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF); functional capacity will be measured with the 6-Minute Walk Test (6MWT); postural stability and balance will be assessed with the Biodex Balance System; clinical balance will be assessed with the Berg Balance Scale; quality of life will be evaluated using the Nottingham Health Profile (NHP)
Interventions
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Observational Assessment
The demographic, clinical, and personal characteristics of the individuals will be collected and recorded through a questionnaire. For all participants, body fat percentage (%), skeletal muscle mass percentage (%), visceral fat percentage (%), and resting metabolic rate (kcal), measured using the Omron Body Composition Monitor, will be recorded. Waist and hip circumference will be measured with a tape measure; lower extremity muscle strength (M. Quadriceps) will be assessed with a muscle hand-held dynamometer; grip strength will be assessed with a hand grip dynamometer; physical activity level will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF); functional capacity will be measured with the 6-Minute Walk Test (6MWT); postural stability and balance will be assessed with the Biodex Balance System; clinical balance will be assessed with the Berg Balance Scale; quality of life will be evaluated using the Nottingham Health Profile (NHP)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Principal Investigators
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SEMİRAMİS ÖZYILMAZ, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation
Locations
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Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Rejeski WJ, Lang W, Neiberg RH, Van Dorsten B, Foster GD, Maciejewski ML, Rubin R, Williamson DF; Look AHEAD Research Group. Correlates of health-related quality of life in overweight and obese adults with type 2 diabetes. Obesity (Silver Spring). 2006 May;14(5):870-83. doi: 10.1038/oby.2006.101.
Awotidebe TO, Adedoyin RA, Yusuf AO, Mbada CE, Opiyo R, Maseko FC. Comparative functional exercise capacity of patients with type 2-diabetes and healthy controls: a case control study. Pan Afr Med J. 2014 Nov 7;19:257. doi: 10.11604/pamj.2014.19.257.4798. eCollection 2014.
Other Identifiers
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BezmialemUNV2025
Identifier Type: -
Identifier Source: org_study_id
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