Type 2 Diabetes Mellitus (T2DM)NCT07152509
The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus (T2DM) and Body Mass Index, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Body Mass Index, Functional Capacity
- What is being tested?
- Observational Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Aug 2025to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 35-65 years with a diagnosis of Type 2 Diabetes Mellitus for at least 1 year, attending the Internal Medicine and Diet outpatient clinics, who meet the inclusion criteria and voluntarily agree to participate
Who may be able to join
- Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year
- Being between 35 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
Who cannot join
- vestibular, neurological, or orthopedic disorders that could affect balance and mobility, including a history of stroke;
- uncontrolled cardiovascular or pulmonary disease or a history of myocardial infarction;
- renal impairment;
- diabetic ulcer or peripheral neuropathy;
- pregnancy;
- hemolytic or renal anemia;
- serious visual, hearing, or speech impairments resulting in inadequate cooperation;
- cognitive or mental impairments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul, 34654
About this study
This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). A total of 50 volunteer patients who meet the inclusion criteria will be recruited from the Internal Medicine and Nutrition outpatient clinics of Bezmialem Vakıf University Hospital.
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.
- Being tested
- Observational Assessment
- Keywords
- quality of life, type 2 diabetes mellitus, body mass index, physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional capacity will be evaluated using the 6-minute walk test (6MWT). At the beginning and end of the test, participants' oxygen saturation, heart rate, blood pressure, Borg dyspnea, and fatigue scores will be recorded. The test will be conducted in a 30-meter straight corridor, marked at 10-meter intervals, with chairs placed at both the starting and finishing points. Participants will be instructed to walk for 6 minutes at the fastest pace they can manage without running. To estimate the expected 6MWT distance, the reference equation by Enright et al. will be used in this study.
Measured: At baseline (single assessment)
Assessment of Quality of Life Using the Nottingham Health Profile
To evaluate patients' quality of life, the Nottingham Health Profile (NHP) will be used. The scale consists of six subdomains: pain, emotional reactions, sleep, social isolation, physical mobility, and energy. Within each subdomain, a score of 0 indicates the best quality of life, while a score of 100 indicates the worst quality of life.
Measured: At baseline (single assessment)
Secondary outcomes (7)
Body Composition
For body composition analysis, the body mass index (BMI) of the participants (Body weight/height²) will be calculated. Using the Omron BF511 Body Composition Monitor (Omron Healthcare Co. Ltd; Japan), body fat percentage (%), skeletal m
Measured: At baseline (single assessment)
waist-to-hip ratio
Waist circumference will be measured in the standing position at the level of the umbilicus during the expiratory phase using a tape measure, and recorded in centimeters ("cm"). Hip circumference will be measured in the same position at the level of the greater trochanter and recorded in centimeters ("cm"). The waist-to-hip ratio will then be calculated.
Measured: At baseline (single assessment)
Lower Extremity Muscle Strength Assessment
Measurement of lower extremity muscle strength will be performed in a seated position, with the dominant leg in full knee extension, by applying maximum resistance using a handheld electronic dynamometer placed just above the ankle joint. The assessment will be conducted on the quadriceps muscle group using a handheld electronic dynamometer (Commander Muscle Tester; JTECH Medical, USA) and recorded in Newtons (N).
Measured: At baseline (single assessment)
Handgrip Strength
Handgrip strength will be measured on the dominant side using a Jamar hand dynamometer and recorded in pounds (lb). The test will be performed while the patients are seated comfortably on a chair, with the shoulder in adduction and neutral position, the elbow at 90° flexion, and the forearm and wrist in a neutral position.
Measured: At baseline (single assessment)
Physical Activity Assessment
Participants' physical activity levels will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ short form consists of seven questions designed to determine, on a daily basis over the past seven days, the time spent in vigorous physical activity (VPA), moderate physical activity (MPA), walking (W), and sitting (sedentary time). To calculate the total physical activity score, the weekly duration (minutes) of each activity is multiplied by the Metabolic Equivalent of Task (MET) values established for the IPAQ, and the resulting scores are obtained. The Turkish validity and reliability study of the IPAQ-Short Form was conducted by Sağlam M. et al.
Measured: At baseline (single assessment)
Assessment of Functional Balance
Patients' functional balance levels will be evaluated using the Turkish version of the Berg Balance Scale (BBS). This scale consists of tasks commonly used in daily life, such as static sitting, standing balance, transfers, turning, and picking up an object from the floor. Each item is scored on a scale from 0 (unable to perform the task) to 4 (normal performance).
Measured: At baseline (single assessment)
Postural stability assessment
Postural stability assessment will be performed using the Biodex Balance System (BBS) (Biodex Medical System, Inc; USA), including the Postural Stability Test for static postural stability and the Limits of Stability Test. The postural stability test evaluates the patient's ability to maintain their center of balance, and deviations from the center are recorded. The limits of stability test assesses the ability to move and control the center of gravity within the base of support. A higher score indicates a higher level of control.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start27 Aug 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEMİRAMİS ÖZYILMAZ, Assoc. Prof., Principal investigator, Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152509
- Sponsor's protocol ID
- BezmialemUNV2025
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for IPD sharing has not yet been determined
Publications
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.
PubMed 16855197Awotidebe 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.
PubMed 25852800
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07152509
- Acronym / sponsor ID
- BezmialemUNV2025
- Keywords
- quality of life, type 2 diabetes mellitus, body mass index, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). A total of 50 volunteer patients who meet the inclusion criteria will be recruited from the Internal Medicine and Nutrition outpatient clinics of Bezmialem Vakıf University Hospital.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus Group | – | Other: Observational AssessmentParticipants 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 35-65 years with a diagnosis of Type 2 Diabetes Mellitus for at least 1 year, attending the Internal Medicine and Diet outpatient clinics, who meet the inclusion criteria and voluntarily agree to participate
Key inclusion criteria (6 listed)
- Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year
- Being between 35 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
Key exclusion criteria (8 listed)
- vestibular, neurological, or orthopedic disorders that could affect balance and mobility, including a history of stroke;
- uncontrolled cardiovascular or pulmonary disease or a history of myocardial infarction;
- renal impairment;
- diabetic ulcer or peripheral neuropathy;
- pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational AssessmentThe 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) | Other | Type 2 Diabetes Mellitus Group |
Primary outcome
Functional capacity
Time frame: At baseline (single assessment)
Functional capacity will be evaluated using the 6-minute walk test (6MWT). At the beginning and end of the test, participants' oxygen saturation, heart rate, blood pressure, Borg dyspnea, and fatigue scores will be recorded. The test will be conducted in a 30-meter straight corridor, marked at 10-meter intervals, with chairs placed at both the starting and finishing points. Participants will be instructed to walk for 6 minutes at the fastest pace they can manage without running. To estimate the expected 6MWT distance, the reference equation by Enright et al. will be used in this study.
Assessment of Quality of Life Using the Nottingham Health Profile
Time frame: At baseline (single assessment)
To evaluate patients' quality of life, the Nottingham Health Profile (NHP) will be used. The scale consists of six subdomains: pain, emotional reactions, sleep, social isolation, physical mobility, and energy. Within each subdomain, a score of 0 indicates the best quality of life, while a score of 100 indicates the worst quality of life.
7 secondary outcomes
Body Composition
Time frame: At baseline (single assessment)
waist-to-hip ratio
Time frame: At baseline (single assessment)
Lower Extremity Muscle Strength Assessment
Time frame: At baseline (single assessment)
Handgrip Strength
Time frame: At baseline (single assessment)
Physical Activity Assessment
Time frame: At baseline (single assessment)
Assessment of Functional Balance
Time frame: At baseline (single assessment)
Postural stability assessment
Time frame: At baseline (single assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publication: PubMed 16855197Rejeski 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.
- Results publication: PubMed 25852800Awotidebe 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.
- Individual participant dataSharing planned: Undecided. The plan for IPD sharing has not yet been determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEMİRAMİS ÖZYILMAZ, Assoc. Prof. principal investigator
Bezmialem Vakıf University,Facult Of Health Sciences, Department Of Physiotherapy And Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Body Mass Index, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: At baseline (single assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.