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Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Irritable Bowel Syndrome and Healthy Subjects

Sponsor
Amir Abbasnezhad (Other)
Overall Status
Completed
CT.gov ID
NCT03366389
Collaborator
Lorestan University of Medical Sciences (Other)
114
Enrollment
1
Location
4.4
Actual Duration (Months)
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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. Furthermore, investigators evaluated the possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical and psychological disorders.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    114 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of the Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Patients With Irritable Bowel Syndrome and Healthy Subjects
    Actual Study Start Date :
    Jun 7, 2017
    Actual Primary Completion Date :
    Sep 16, 2017
    Actual Study Completion Date :
    Oct 20, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Case

    patients with irritable bowel syndrome
    Control

    Healthy subjects without any gastrointestinal disorders, chronic diseases and malignancy.

    Outcome Measures

    Primary Outcome Measures

    1. Serum levels of Apelin, Chemerin and adiponectin [in recruitment]

    Secondary Outcome Measures

    1. IBS-Quality of life (IBS-QoL) [in recruitment]

      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

    2. IBS severity score system (IBSSS) [in recruitment]

      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.

    3. Gastrointestinal symptoms [in recruitment]

    4. Somatic Symptom [in recruitment]

    5. Personality [in recruitment]

      Big Five Inventory Questionnaire

    6. Perceived Stress Scale [in recruitment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lorestan university of medical sciences Khorramabad Iran, Islamic Republic of

    Sponsors and Collaborators

    • Amir Abbasnezhad
    • Lorestan University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amir Abbasnezhad, Assistant Professor of Nutrition Science, Lorestan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03366389
    Other Study ID Numbers:
    • Lums.REC.1396.266
    First Posted:
    Dec 8, 2017
    Last Update Posted:
    Dec 8, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Syndrome

    Study Results

    No Results Posted as of Dec 8, 2017