Irritable Bowel SyndromeNCT03366389
Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Irritable Bowel Syndrome and Healthy Subjects
An observational study of Irritable Bowel Syndrome, run by Amir Abbasnezhad at 1 site in Iran.
Trial summary
In this observational case-control study investigators aimed to assess the serum levels of adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome (IBS), and compare it with healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 114 participants
- Where
- 1 siteIran
- Study dates
- 7 Jun 2017to 20 Oct 2017
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited from the outpatient clinic at the Lorestan University of Medical Sciences, Khorramabad, Iran, by an attendant gastroenterologist.
Who may be able to join
- Men and women between the ages of 18, and 80 years.
- IBS patients diagnosed according to the Rome III Diagnostic Criteria for Functional GI Disorders.
Who cannot join
- Any evidence of abdominal surgery or radiation
- celiac disease, or other primary GI illnesses
- GI infection obscuring IBS symptoms,
- using total parenteral nutrition therapy in the last 6 months
- pregnancy and lactation
- alcohol consumption
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- concurrent chronic diseases such as diabetes, renal failure
- diagnosed and/or treated malignancy in the past 5 years
- anti-inflammatory drugs usage
- intake of vitamin D, omega-3, vitamin E, and calcium supplements
- being on a special diet or medication regimen during the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Patients With Irritable Bowel Syndrome and Healthy Subjects
In this observational case-control study investigators aimed to assess the serum levels of adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical and psychological disorders.
- Conditions
- Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | patients with irritable bowel syndrome | |
| Control | Healthy subjects without any gastrointestinal disorders, chronic diseases and malignancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Apelin, Chemerin and adiponectin
Measured: in recruitment
Secondary outcomes (6)
IBS-Quality of life (IBS-QoL)
The Quality of life was assessed at the baseline and at the end of the study using a self-report QoL measure specific to IBS (IBS-QoL) with 34 items
Measured: in recruitment
IBS severity score system (IBSSS)
Irritable bowel syndrome severity score system is validated for use in IBS patients, which included five clinically relevant items during a 10-day period: (i) severity of abdominal pain, (ii) frequency of abdominal pain, (iii) severity of abdominal distention or tightness, (iv) dissatisfaction with bowel habits, and (v) interference of IBS with life in general. Each item was scored on a scale from 0 to 100, and the sum of these five items was the score of IBS severity (range 0-500). Scores of 75-175, 175-300, and >300 indicated mild, moderate, and severe cases, respectively.
Measured: in recruitment
Gastrointestinal symptoms
Measured: in recruitment
Somatic Symptom
Measured: in recruitment
Personality
Big Five Inventory Questionnaire
Measured: in recruitment
Perceived Stress Scale
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.Higher PSS scores were associated with a greater vulnerability to stressful life-event-elicited depressive symptoms.
PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.
Measured: in recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start7 Jun 2017
- Primary completion16 Sep 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel 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
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amir Abbasnezhad
- Sponsor type
- University, hospital or other
- Collaborators
- Lorestan University of Medical Sciences
- Responsible party
- Sponsor-investigator, Amir Abbasnezhad, Lorestan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366389
- Sponsor's protocol ID
- Lums.REC.1396.266
- Status last verified
- Dec 2017
- First submitted
- 10 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Patients With Irritable Bowel Syndrome and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03366389
- Acronym / sponsor ID
- Lums.REC.1396.266
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Amir AbbasnezhadUniversity, hospital or other
- Collaborators
- Lorestan University of Medical Sciences
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 16 Sep 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 8 Dec 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.
In this observational case-control study investigators aimed to assess the serum levels of adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical and psychological disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –patients with irritable bowel syndrome |
| Control | – | –Healthy subjects without any gastrointestinal disorders, chronic diseases and malignancy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the outpatient clinic at the Lorestan University of Medical Sciences, Khorramabad, Iran, by an attendant gastroenterologist.
Key inclusion criteria (2 listed)
- Men and women between the ages of 18, and 80 years.
- IBS patients diagnosed according to the Rome III Diagnostic Criteria for Functional GI Disorders.
Key exclusion criteria (11 listed)
- Any evidence of abdominal surgery or radiation
- celiac disease, or other primary GI illnesses
- GI infection obscuring IBS symptoms,
- using total parenteral nutrition therapy in the last 6 months
- pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum levels of Apelin, Chemerin and adiponectin
Time frame: in recruitment
6 secondary outcomes
IBS-Quality of life (IBS-QoL)
Time frame: in recruitment
IBS severity score system (IBSSS)
Time frame: in recruitment
Gastrointestinal symptoms
Time frame: in recruitment
Somatic Symptom
Time frame: in recruitment
Personality
Time frame: in recruitment
Perceived Stress Scale
Time frame: in recruitment
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 8 Dec 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irritable Bowel Syndrome, run by Amir Abbasnezhad at 1 site in Iran.
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 2 inclusion and 11 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 8 Dec 2017. 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 Iran. 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?
Serum levels of Apelin, Chemerin and adiponectin (time frame: in recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2017.