Pre-analytical Influences on a Blood Test Study

NCT05434949 | Completed DMC

• 1 other identifier: 2022LAB126
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4. In order to determine whether 7aC4 could be a good test for BAD, it needs to be determined whether eating a meal can alter the levels of 7aC4. The aim of this study is to measure 7aC4 at several time points before and after eating a meal, to see what effect this has on 7aC4 levels.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.

  Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.

  12 months

• Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).

  Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).

  12 months

Study Arms (2)

Effect of food intake on C4

Blood tests to analyse serum C4 pre, and 2 and 4 hours post a standardised meal, and the same 10 patients to analyse serum C4 at 0, 2 and 4 hours, all fasting.

Diagnostic Test: Blood test

Effect of Lipid-lowering therapy on C4

Spare sample collected from patients before and after starting on lipid-lowering therapy will be used to measure C4 before and after lipid-lowering therapy.

Other: Analyses of samples

Interventions

Blood test DIAGNOSTIC_TEST

Three blood samples to be taken at 08.00, 10.00 and 12.00 on day 1 of the study. The following day, after an overnight fast, a blood sample will be taken at 8.00, followed by a standardized breakfast provided by the study team at 8.30, and then two further blood samples at 10.00 and 12.00.

Effect of food intake on C4

Analyses of samples OTHER

C4 will be measured in surplus serum from 30 adult lipid patients before starting on lipid-lowering therapy (either statin of PCSK9 therapy) and then again 3 months after starting on therapy. Blood samples will be collected as part of routine lipid management, no additional samples are required.

Effect of Lipid-lowering therapy on C4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers from the BCPS and patients attending hospital as part of their standard care.

You may qualify if:

• Part 1: Effect of food intake on C4
• Healthy adult (\>=18 years) volunteers from the BCPS.
• Part 2: Effect of Lipid-lowering therapy on C4
• There is no patient recruitment. Spare sample collected from patients before and after starting on lipid-lowering therapy will be used.

You may not qualify if:

• Part 1: Effect of food intake on serum C4
• Subjects with learning disability or those lacking mental capacity to give consent.
• Pregnant or breast-feeding
• On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
• Chronic and acute diarrhoea
• Gastrointestinal disease.
• Previous ileal resection or cholecystectomy
• Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2
• Part 2: Effect of Lipid-lowering therapy on C4
• The surplus serum will not be analysed if any of the following apply to the patient:
• Pregnant or breastfeeding for either time point
• Lipid lowering therapy within the last 6 months for the first sample
• On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
• Chronic and acute diarrhoea
• Gastrointestinal disease.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 28, 2022
• Study Start: December 1, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

GB (1)