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

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT03366389
• Lead Sponsor: Amir Abbasnezhad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Primary Completion: 2017-09-16
• Study Completion: 2017-10-20
• Study First Submitted: 2017-11-10
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of Apelin, Chemerin and adiponectin	in recruitment

Secondary Outcome Measures

Name	Time	Method
Somatic Symptom	in recruitment
Gastrointestinal symptoms	in recruitment
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
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.
Personality	in recruitment	Big Five Inventory Questionnaire
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.

Trial Locations

Locations (1)

Lorestan university of medical sciences; 🇮🇷 Khorramabad, Iran, Islamic Republic of