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NCT Number: NCT03366389

Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lorestan university of medical sciences

Khorramabad, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum levels of Apelin, Chemerin and adiponectin

    Time frame: in recruitment

Secondary outcomes

  1. IBS-Quality of life (IBS-QoL)

    Time frame: 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)

    Time frame: 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

    Time frame: in recruitment

  4. Somatic Symptom

    Time frame: in recruitment

  5. Personality

    Time frame: in recruitment

    Big Five Inventory Questionnaire

  6. Perceived Stress Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amir Abbasnezhad

Other

Collaborators

  • Lorestan University of Medical Sciences

Registry information

Official study title

Evaluation of the Serum Levels of Apelin, Chemerin and Adiponectin Adipokines in Patients With Irritable Bowel Syndrome and Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2017
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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