Breath for Better Health Study
Condition: Type2 Diabetes
Study type: Interventional

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.
    

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.
    

Intervention name(s): Orange juice
Intervention type(s): Dietary Supplement
Intervention description(s): Sub group I will drink Orange juice and have repeat measures.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic