Metabolic SyndromeNCT03338868
Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Ataturk Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Body composition, Physical activity level and Musculoskeletal pain intensity
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2015to 30 Dec 2017
- How long will I take part?
- 2 Days
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having chronic musculoskeletal pain with and without metabolic syndrome
Who may be able to join
- To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.
Who cannot join
- the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Active, not recruiting
Ataturk Training and Research Hospital
Ankara, Cankaya, 06800
- Recruiting
Ataturk Training and Research Hospital
Ankara, Cankaya, 06800
Seyda Toprak Celenay, Assist Prof, +90 530 041 39 86, sydtoprak@hotmail.com
About this study
Official title: Comparison of Serum Concentrations, Physical and Psychological Well-being in Patients Having Chronic Musculoskeletal Pain With and Without Metabolic Syndrome
The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.
Read the detailed description
Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated.
Presence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.
- Conditions
- Metabolic Syndrome
- Being tested
- Body composition, Physical activity level, Musculoskeletal pain intensity, Quality of life, Psychological Well-Being
- Keywords
- physical activity, pain, uric acid
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body compositionOther
evaluated by Bodystat®1500 Bio-impedance Analyzer
Physical activity levelOther
assessed by the International Physical Activity Questionnaire-7
Musculoskeletal pain intensityOther
evaluated with Visual Analog Scale
Quality of lifeOther
assessed by the Nottingham Health Profile
Psychological Well-BeingOther
assessed by the Hospital Anxiety and Depression Scale
Blood testsDiagnostic test
Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MetS | To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. Receives: Other: Body composition; Other: Physical activity level; Other: Musculoskeletal pain intensity; Other: Quality of life; Other: Psychological Well-Being; Diagnostic Test: Blood tests | |
| Patients without MetS | To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. Receives: Other: Body composition; Other: Physical activity level; Other: Musculoskeletal pain intensity; Other: Quality of life; Other: Psychological Well-Being; Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood tests
for uric acid levels.
Measured: 2 years
Secondary outcomes (5)
Body composition
evaluated by Bodystat®1500 Bio-impedance Analyzer
Measured: 2 years
Physical activity level
assessed by the International Physical Activity Questionnaire-7. The intensity of self-reported physical activity, lasting at ten minutes per bout, was used to assess metabolic equivalent (MET). The MET is defined as the ratio of a working metabolic rate to a standard resting metabolic rate.MET-minutes/week was computed by multiplying the MET score of an activity (3.3 for walking, 4.0 for moderate-intensity, and 8.0 for vigorous-intensity) by the minutes and days performed. The summation of walking, moderate, and vigorous METs-minutes/week enabled the computation of the total physical activity performed by an individual.
Measured: 2 years
The musculoskeletal pain intensity
evaluated with 0 to 10 cm Visual Analog Scale. "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".
Measured: 2 years
Quality of life
evaluated with the Nottingham Health Profile (NHP). It contains 38 items divided into 6 dimensions: NHP-energy, NHP-pain, NHP-emotional reactions, NHP sleep, NHP-social isolation, and NHP-physical mobility. All the parameters are summed as NHP-total. The respondent answers "yes" if the statement adequately reflected the current status or feeling, or "no" otherwise. Dimension scores ranged from 0 (no problems) to 100 (maximum problems).
Measured: 2 years
Psychological Well-Being (Anxiety and Deppression condition)
evaluated with the Hospital Anxiety and Depression Scale (HADS). Each question was scored on a 4-point Likert scale, ranging from 0 to 3, where a higher score represented more severe anxiety or depression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Aug 2015
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda Toprak Celenay, Assist prof, Study director, Ankara Yildirim Beyazit University Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338868
- Sponsor's protocol ID
- 2015-13/32
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Afzal N, Mahmud TE, Jahan SS, Kundi S. Uric acid profile in patients with chronic nonspecific musculoskeletal pain. J Ayub Med Coll Abbottabad. 2003 Oct-Dec;15(4):5-9.
PubMed 15067822Fu YQ, Yang H, Zheng JS, Zeng XY, Zeng W, Fan ZF, Chen M, Wang L, Li D. Positive association between metabolic syndrome and serum uric acid in Wuhan. Asia Pac J Clin Nutr. 2017 Mar;26(2):343-350. doi: 10.6133/apjcn.012016.06.
PubMed 28244715Chu AH, Moy FM. Association between physical activity and metabolic syndrome among Malay adults in a developing country, Malaysia. J Sci Med Sport. 2014 Mar;17(2):195-200. doi: 10.1016/j.jsams.2013.04.003. Epub 2013 May 9.
PubMed 23665093Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpcao CM, Londero F. Metabolic syndrome and quality of life: a systematic review. Rev Lat Am Enfermagem. 2016 Nov 28;24:e2848. doi: 10.1590/1518-8345.1573.2848.
PubMed 27901223Takeuchi T, Nakao M, Nomura K, Inoue M, Tsurugano S, Shinozaki Y, Yano E. Association of the metabolic syndrome with depression and anxiety in Japanese men: a 1-year cohort study. Diabetes Metab Res Rev. 2009 Nov;25(8):762-7. doi: 10.1002/dmrr.1041.
PubMed 19839027
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum Concentrations, Physical and Psychological Well-being in Patients Having Chronic Musculoskeletal Pain With and Without Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03338868
- Acronym / sponsor ID
- 2015-13/32
- Conditions
- Metabolic Syndrome
- Keywords
- physical activity, pain, uric acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 9 Nov 2017 (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.
The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.
Detailed description
Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated.
Presence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MetS | – | Other: Body composition, Other: Physical activity level, Other: Musculoskeletal pain intensity, Other: Quality of life, Other: Psychological Well-Being, Diagnostic Test: Blood testsTo be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. |
| Patients without MetS | – | Other: Body composition, Other: Physical activity level, Other: Musculoskeletal pain intensity, Other: Quality of life, Other: Psychological Well-Being, Diagnostic Test: Blood testsTo be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having chronic musculoskeletal pain with and without metabolic syndrome
Key inclusion criteria (1 listed)
- To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.
Key exclusion criteria (1 listed)
- the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.
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 |
|---|---|---|
| Body compositionevaluated by Bodystat®1500 Bio-impedance Analyzer | Other | Patients with MetS, Patients without MetS |
| Physical activity levelassessed by the International Physical Activity Questionnaire-7 | Other | Patients with MetS, Patients without MetS |
| Musculoskeletal pain intensityevaluated with Visual Analog Scale | Other | Patients with MetS, Patients without MetS |
| Quality of lifeassessed by the Nottingham Health Profile | Other | Patients with MetS, Patients without MetS |
| Psychological Well-Beingassessed by the Hospital Anxiety and Depression Scale | Other | Patients with MetS, Patients without MetS |
| Blood testsBlood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting. | Diagnostic test | Patients with MetS, Patients without MetS |
Primary outcome
Blood tests
Time frame: 2 years
for uric acid levels.
5 secondary outcomes
Body composition
Time frame: 2 years
Physical activity level
Time frame: 2 years
The musculoskeletal pain intensity
Time frame: 2 years
Quality of life
Time frame: 2 years
Psychological Well-Being (Anxiety and Deppression condition)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 15067822Afzal N, Mahmud TE, Jahan SS, Kundi S. Uric acid profile in patients with chronic nonspecific musculoskeletal pain. J Ayub Med Coll Abbottabad. 2003 Oct-Dec;15(4):5-9.
- Results publication: PubMed 28244715Fu YQ, Yang H, Zheng JS, Zeng XY, Zeng W, Fan ZF, Chen M, Wang L, Li D. Positive association between metabolic syndrome and serum uric acid in Wuhan. Asia Pac J Clin Nutr. 2017 Mar;26(2):343-350. doi: 10.6133/apjcn.012016.06.
- Results publication: PubMed 23665093Chu AH, Moy FM. Association between physical activity and metabolic syndrome among Malay adults in a developing country, Malaysia. J Sci Med Sport. 2014 Mar;17(2):195-200. doi: 10.1016/j.jsams.2013.04.003. Epub 2013 May 9.
- Results publication: PubMed 27901223Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpcao CM, Londero F. Metabolic syndrome and quality of life: a systematic review. Rev Lat Am Enfermagem. 2016 Nov 28;24:e2848. doi: 10.1590/1518-8345.1573.2848.
- Results publication: PubMed 19839027Takeuchi T, Nakao M, Nomura K, Inoue M, Tsurugano S, Shinozaki Y, Yano E. Association of the metabolic syndrome with depression and anxiety in Japanese men: a 1-year cohort study. Diabetes Metab Res Rev. 2009 Nov;25(8):762-7. doi: 10.1002/dmrr.1041.
- Individual participant dataSharing planned: Undecided
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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.
Seyda Toprak Celenay, Assist prof study director
Ankara Yildirim Beyazit University Ataturk Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Ataturk Training and Research Hospital at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay, Asist Prof (+90 530 041 3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood tests (time frame: 2 years). 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 NCT03338868, which also lists 5 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 17 Nov 2017.