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Breath for Better Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210896
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
University of Warwick
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Orange juice Not Applicable

Detailed Description:

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.

As a biological waste media, it has many advantages over other more invasive approaches. It can be given at will with a large volume of potential sample, it has a high level of patient acceptability, it is non-invasive, sample collection is very quick and it is potentially possible to analyse the sample in almost real-time. This has made breath analysis a target focus for many groups working on a broad range of diseases. Previous studies, by the investigators group and others have shown that breath analysis can be used to identify patients with irritable bowel diseases, hepatic encephalopathy, cancers (specifically colorectal and breast) and respiratory infections (such as tuberculosis).

Though these previous projects have shown promise, it is only now that our ability to make highly sensitive gas analysis instruments and sensors makes it a real possibility to bring this to the wider public. However, to be able to develop such sensors and sensor systems, the investigators need to identify the specific chemical biomarkers in the breath to detect and measure. At this point in time, there is no such definitive list of biomarkers (potential or otherwise) for all possible disease groups. In addition, where there are proposed markers, there is no agreement in the field on what these are.

The final goal of this project is to produce a new device that will allow simple, non-invasive monitoring of diabetic patients, which the investigators believe will lead to a significant improvement in the quality of life of those suffering from this condition.

The purpose of this study is partly to discover new potential biomarkers in human breath associated with diabetes and from this, try and understand what confounding factors may affect its efficacy. The investigators believe that these confounding factors maybe sex, age, diet and food and others. Without a deep understanding of these variables, it will be impossible to develop a new generation of person monitoring tools.

To maximise the chances of discovering new potential biomarkers, the investigators will deploy a range of different analytical instruments aimed at different parts of the chemical spectrum. Together, the investigators believe they will be able to get a comprehensive understanding of the chemicals being released in human breath, how these are affected by confounding factors and how they are related to blood sugar levels.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breath for Better Health Study
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : May 8, 2019
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Main Group
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.
Experimental: Sub Group I
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 I will drink Orange juice and have repeat measures.

No Intervention: Sub Group II
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.



Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours. ]
    Repeat breath samples will be collected over time to measure changes in chemical components.

  2. 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. [ Time Frame: Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours. ]
    Repeat breath samples will be collected over time to measure changes in chemical components.

  3. 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. [ Time Frame: Baseline, 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours. ]
    Repeat breath samples will be collected over time to measure changes in chemical components.


Secondary Outcome Measures :
  1. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as age will be recorded to see if they influence the breath chemical composition.

  2. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as sex will be recorded to see if they influence the breath chemical composition.

  3. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as smoking habits will be recorded to see if they influence the breath chemical composition.

  4. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as medication will be recorded to see if they influence the breath chemical composition.

  5. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as food intake will be recorded to see if they influence the breath chemical composition.

  6. Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition. [ Time Frame: Baseline ]
    Confounding factors such as physical activities will be recorded to see if they influence the breath chemical composition.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Diagnosed clinically with type 2 diabetes

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210896


Locations
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United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Investigators
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Principal Investigator: Ramesh Arasaradanam Consultant
Publications:
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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03210896    
Other Study ID Numbers: RA315217
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No