Type2 DiabetesNCT03210896
Breath for Better Health Study
A study testing Orange juice in people with Type2 Diabetes, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to 8 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed clinically with type 2 diabetes
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceDietary supplement
Sub group I will drink Orange juice and have repeat measures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Confounding factors such as age will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Confounding factors such as sex will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Confounding factors such as smoking habits will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Confounding factors such as medication will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Confounding factors such as food intake will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Confounding factors such as physical activities will be recorded to see if they influence the breath chemical composition.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start10 Jul 2017
- Primary completion8 May 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick
- Responsible party
- Sponsor
- Investigators
- Ramesh Arasaradanam, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210896
- Sponsor's protocol ID
- RA315217
- Status last verified
- Sep 2019
- First submitted
- 21 Jun 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26682719Arasaradnam 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.
PubMed 26866470Amal 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.
PubMed 26212114Phillips 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.
PubMed 16502014Sahota 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.
PubMed 27450016
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath for Better Health Study
- ClinicalTrials.gov ID
- NCT03210896
- Acronym / sponsor ID
- RA315217
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University of Warwick
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Orange juice20 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed clinically with type 2 diabetes
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceSub group I will drink Orange juice and have repeat measures. | Dietary supplement | Sub Group I |
Primary outcome
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.
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.
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.
6 secondary outcomes
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Demographic and lifestyle data will be recorded to see if they correlate with breath chemical composition.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Background: PubMed 26682719Arasaradnam 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.
- Background: PubMed 26866470Arasaradnam 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.
- Background: PubMed 26212114Amal 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.
- Background: PubMed 16502014Phillips 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.
- Background: PubMed 27450016Sahota 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh Arasaradanam principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Type2 Diabetes, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210896, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.