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Status unknownNCT03338868Updated Nov 17, 2017

Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome

An observational study in Metabolic Syndrome, sponsored by Ataturk Training and Research Hospital. Status unknown at 2 sites in Turkey. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Ataturk Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Metabolic Syndrome with a site in Turkey — 13 open to participants now, 15 under way, none of them phase 3. Metabolic Syndrome · Turkey.

Planned enrollment
18th of 33
100 · median 104
Started
2015
the only one that year
Observational
33 of 53
12 open now
Registered
10th of 53
by date

Among the 53 studies in Metabolic Syndrome with a site in Turkey, this one is the 18th largest by planned enrollment of the 33 observational ones that give a count, is the only one that started in 2015, is one of 33 observational ones, and was the 10th registered.

Metabolic Syndrome

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

Browse Metabolic Syndrome studies →

Open to participants now

13 of the 53 studies in Metabolic Syndrome with a site in Turkey are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 232 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 136 (59%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.

This study: 20 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Metabolic Syndrome

Keywords

  • physical activity
  • pain
  • uric acid
04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients having chronic musculoskeletal pain with and without metabolic syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
2 Days
Patient registry
Yes

Groups and cohorts

  • 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.

    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.

    Other: Body composition · Other: Physical activity level · Other: Musculoskeletal pain intensity · Other: Quality of life · Other: Psychological Well-Being · Diagnostic Test: Blood tests

Interventions

  • OtherBody composition

    evaluated by Bodystat®1500 Bio-impedance Analyzer

  • OtherPhysical activity level

    assessed by the International Physical Activity Questionnaire-7

  • OtherMusculoskeletal pain intensity

    evaluated with Visual Analog Scale

  • OtherQuality of life

    assessed by the Nottingham Health Profile

  • OtherPsychological Well-Being

    assessed by the Hospital Anxiety and Depression Scale

  • Diagnostic testBlood tests

    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.

06

What researchers measure

Primary outcomes

  1. Blood tests

    for uric acid levels.

    Time frame: 2 years

Secondary outcomes

  1. Body composition

    evaluated by Bodystat®1500 Bio-impedance Analyzer

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. 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".

    Time frame: 2 years

  4. 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).

    Time frame: 2 years

  5. 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.

    Time frame: 2 years

07

Study locations

1 of 2 sites recruiting
  • Ataturk Training and Research Hospital
    Ankara, Cankaya 06800, Turkey
    Active, not recruiting
  • Ataturk Training and Research Hospital
    Ankara, Cankaya 06800, Turkey
    Recruiting
08

References and documents

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 15067822 ↗
  • Fu 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 28244715 ↗
  • Chu 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 23665093 ↗
  • Saboya 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 27901223 ↗
  • Takeuchi 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2015 (actual). Primary completion is estimated for Nov 2017, 27 months after the start.

Of 149 non-industry observational studies under Metabolic Syndrome, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 106. This study's planned 27 months is below that.

Counting every sponsor, half of 160 studies reached it within 42 months; a quarter within 18 and three quarters within 106.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Nov 9, 2017
StartActual
Aug 1, 2015
Primary completionEst.
Nov 30, 2017
CompletionEst.
Dec 30, 2017
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03338868
Lead sponsor
Ataturk Training and Research Hospital
Responsible party
Seyda TOPRAK CELENAY (Assistant Professor, PT, PhD, Ataturk Training and Research Hospital) — Principal investigator
First posted
Nov 9, 2017
Start date
Aug 1, 2015
Primary completion
Nov 30, 2017 (estimated)
Completion
Dec 30, 2017 (estimated)
Last update
Nov 17, 2017

Study contacts

Seyda Toprak Celenay, Asist Prof
Contact
sydtoprak@hotmail.com
+90 530 041 3986
Seyda Toprak Celenay, Assist prof
study director · Ankara Yildirim Beyazit University Ataturk Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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