Breath for Better Health Study

NCT03210896 | Completed

• 1 other identifier: RA315217
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Breath analysis is becoming of increasing interest to researchers throughout the world for disease identification and monitoring. It is known that small chemicals dissolved in the blood can pass through the blood/air barrier within the lungs and be exhaled in normal breath, with many of these chemicals being potential biomarkers for a broad range of diseases. These specific biomarkers need to be identified so that gas analysis instruments and sensors can be designed to detect these chemicals. The aim of this study is to determine if there are biomarkers in exhaled breath that correlate with blood glucose concentration. This biomarker can then be used to produce a new device that will allow diabetic patients to monitor their blood glucose levels in a quick and non-invasive way. The investigators believe this will lead to a significant improvement in the quality of life of those suffering from this condition. In this study breath samples will be collected using three different methods to maximise the chemical information available from each breath. Breath samples from Type 2 diabetic patients will be compared with healthy controls. Subgroups will have repeated breath samples after drinking orange juice or during normal day-to-day activities. This is to measure any changes in breath chemicals over time. The chemicals detected will be compared with blood tests, to identify potential breath biomarkers for blood glucose concentration, and to see if factors such as sex, age, and diet have any effect on the biomarkers detected. This is a single centre pilot study taking place at University Hospitals Coventry and Warwickshire NHS Trust, and the analysis of the breath samples will be carried out at the University of Warwick.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Chemical components in breath samples will be measured using Ion Mobility Spectrometry, to determine if there are potential biomarkers in exhaled breath that can be directly correlated with blood glucose concentration.

  Repeat breath samples will be collected over time to measure changes in chemical components.

  Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours.

• Chemical components in breath will be captured into a plastic tubes (Bio-VOC) followed by Electronic Nose analysis, to determine if there are potential biomarkers in exhaled breath that can be directly correlated with blood glucose concentration.

  Repeat breath samples will be collected over time to measure changes in chemical components.

  Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours.

• Chemical components in breath will be captured into absorbent tubes followed by GCMS analysis, to determine if there are potential biomarkers in exhaled breath that can be directly correlated with blood glucose concentration.

  Repeat breath samples will be collected over time to measure changes in chemical components.

  Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours.

Secondary Outcomes (6)

• Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.

  Baseline

• Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.

  Baseline

• Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.

  Baseline

• Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.

  Baseline

• Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.

  Baseline

Study Arms (3)

Main Group

NO INTERVENTION

100 subjects (70 T2D and 30 Controls) consent to provide 1 venous blood sample, 1 capillary blood sample and 3 breath samples using IMSPEX, Bio-VOC and ReCIVA breath samplers.

Sub Group I

EXPERIMENTAL

20 subjects from the main group (10 T2D and 10 Controls) to remain after providing the above samples. These patients will stay for an additional 3 hours and provide 1 capillary blood sample and 3 breath samples using IMSPEX, Bio-VOC and ReCIVA breath samplers at the following time intervals: 5, 30, 60, 120 \& 180 minutes.

Dietary Supplement: Orange juice

Sub Group II

NO INTERVENTION

5 control subjects consent to provide 1 venous blood sample, 1 capillary blood sample and 3 breath samples using IMSPEX, Bio-VOC and ReCIVA breath samplers. This will be followed by 1 capillary blood sample and 3 breath samples every hour for a total of 5 hours.

Interventions

Orange juice DIETARY_SUPPLEMENT

Sub group I will drink Orange juice and have repeat measures.

Sub Group I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosed clinically with type 2 diabetes

You may not qualify if:

• Consumed alcohol less than 48 hours before the start of the study appointment
• Consumed food or drink less than 1 hour before the start of the study appointment
• Smoked less than 2 hours before the start of the study appointment
• Pregnant
• Person who has (or had in the last week) a respiratory infection (either bacterial or viral)
• Uses recreational drugs
• Those who have had surgery/major injury in the last 4 months
• Anyone with a different metabolic, liver, cancer or gastro related disease
• Anyone who is taking part in an interventional study
• Anyone who is unable to provide written consent

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (5)

• Arasaradnam RP, McFarlane M, Daulton E, Skinner J, O'Connell N, Wurie S, Chambers S, Nwokolo C, Bardhan K, Savage R, Covington J. Non-invasive exhaled volatile organic biomarker analysis to detect inflammatory bowel disease (IBD). Dig Liver Dis. 2016 Feb;48(2):148-53. doi: 10.1016/j.dld.2015.10.013. Epub 2015 Nov 22.

  PMID: 26682719 BACKGROUND

• Arasaradnam RP, McFarlane M, Ling K, Wurie S, O'Connell N, Nwokolo CU, Bardhan KD, Skinner J, Savage RS, Covington JA. Breathomics--exhaled volatile organic compound analysis to detect hepatic encephalopathy: a pilot study. J Breath Res. 2016 Feb 11;10(1):016012. doi: 10.1088/1752-7155/10/1/016012.

  PMID: 26866470 BACKGROUND

• Amal H, Leja M, Funka K, Lasina I, Skapars R, Sivins A, Ancans G, Kikuste I, Vanags A, Tolmanis I, Kirsners A, Kupcinskas L, Haick H. Breath testing as potential colorectal cancer screening tool. Int J Cancer. 2016 Jan 1;138(1):229-36. doi: 10.1002/ijc.29701. Epub 2015 Aug 7.

  PMID: 26212114 BACKGROUND

• Phillips M, Cataneo RN, Ditkoff BA, Fisher P, Greenberg J, Gunawardena R, Kwon CS, Tietje O, Wong C. Prediction of breast cancer using volatile biomarkers in the breath. Breast Cancer Res Treat. 2006 Sep;99(1):19-21. doi: 10.1007/s10549-006-9176-1. Epub 2006 Feb 24.

  PMID: 16502014 BACKGROUND

• Sahota AS, Gowda R, Arasaradnam RP, Daulton E, Savage RS, Skinner JR, Adams E, Ward SA, Covington JA. A simple breath test for tuberculosis using ion mobility: A pilot study. Tuberculosis (Edinb). 2016 Jul;99:143-146. doi: 10.1016/j.tube.2016.05.005. Epub 2016 May 29.

  PMID: 27450016 BACKGROUND

Study Officials

• Ramesh Arasaradanam

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: July 7, 2017
• Study Start: July 10, 2017
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)