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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366389
• Other study ID #: Lums.REC.1396.266
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: December 7, 2017
• Start date: June 7, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: December 2017
• Source: Lorestan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 20, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Iran, Islamic Republic of	Lorestan university of medical sciences	Khorramabad

Sponsors (2)

Lead Sponsor	Collaborator
Amir Abbasnezhad	Lorestan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of Apelin, Chemerin and adiponectin		in recruitment
Secondary	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	in recruitment
Secondary	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.	in recruitment
Secondary	Gastrointestinal symptoms		in recruitment
Secondary	Somatic Symptom		in recruitment
Secondary	Personality	Big Five Inventory Questionnaire	in recruitment
Secondary	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.	in recruitment