Development of a non-invasive and accurate diagnostic method for type 2 diabetes using acetone in urine samples
| ISRCTN | ISRCTN12308193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12308193 |
| Secondary identifying numbers | LHJJ2020006 |
- Submission date
- 23/11/2021
- Registration date
- 25/11/2021
- Last edited
- 26/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes (T2D) is a common condition that causes the level of sugar (glucose) in the blood to become too high and accounts for more than 90% of the confirmed cases of diabetes. It has become a common underlying metabolic disease and is expected to affect 380 million people worldwide in 2025. At present, the diagnosis of type 2 diabetes is mainly based on fasting plasma glucose (FPG), the oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA1c), but there are a few methods of non-invasive screening. The aim of this study is to study the association between acetone levels in the urine headspace (the gas above the contents of a sealed urine sample) and T2D .
Who can participate?
Patients with type 2 diabetes and healthy people with a normal physical examination, aged 18-90 years
What does the study involve?
Participants are asked to provide 2 ml urine samples and levels of acetone are measured using proton transfer reaction mass spectrometry.
What are the possible benefits and risks of participating?
Participation in this study will give the participants a better understanding of their physical health and diabetic diseases. Only waste urine routine samples are used, without risk.
Where is the study run from?
The Chinese Academy of Sciences and the Second Affiliated Hospital of Anhui Medical University (China)
When is the study starting and how long is it expected to run for?
March 2020 to May 2022
Who is funding the study?
1. The Second Affiliated Hospital of Anhui Medical University (China)
2. Hefei Institutes of Physical Science, Chinese Academy of Sciences (China)
Who is the main contact?
Xue Zou
xzou@cmpt.ac.cn
Contact information
Scientific
350 Shushanhu Road Hefei 230031,Anhui, P. R. China
Hefei
230031
China
| Phone | +86 (0)551 65595179 |
|---|---|
| xzou@cmpt.ac.cn |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Non-invasive and accurate diagnosis of type 2 diabetes using urinary acetone: a prospective multicenter study |
| Study objectives | Urinary acetone can be used for the diagnosis of type 2 diabetes (T2D). |
| Ethics approval(s) | Approved 17/03/2020, The Second Hospital of Anhui Medical University Ethics Committee (No. 678, Furong Road, Hefei Economic and Technological Development Zone, Anhui Province, China; +86 (0)551 63806061; aydefyllwyhbgs@126.com), ref: YX2021-113 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Each participant is asked to provide a 2 ml urine sample. Acetone in the headspace of urine in sealed bottles is quantitatively analyzed by mass spectrometry. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Urinary acetone is measured using proton transfer reaction mass spectrometry in less than 8 h after sampling |
| Secondary outcome measures | 1. Fasting blood glucose is detected using a blood glucose monitor in less than 4 h after sampling 2. A1c is detected using a glycosylated hemoglobin automatic analyzer in less than 4 h after sampling |
| Overall study start date | 10/03/2020 |
| Completion date | 01/05/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. All T2D patients diagnosed in each hospital and found to have abnormal high fasting plasma glucose (FPG) levels less than 1 week before the experiments 2. Healthy subjects chosen from people undergoing health examinations in these hospitals 3. Age range: 18-90 years |
| Key exclusion criteria | Participants in the healthy control group are required to have no neurological, endocrine or other systemic diseases and no acute and chronic inflammatory or infectious diseases |
| Date of first enrolment | 20/04/2021 |
| Date of final enrolment | 01/04/2022 |
Locations
Countries of recruitment
- China
Study participating centres
Economic and Technological Development Zone
Hefei
230601
China
Luyang District
Hefei
230002
China
Shushan District
Hefei
230022
China
Sponsor information
Research organisation
350 Shushanhu Road
Hefei
230031
China
| Phone | +86 (0)551 65591245 |
|---|---|
| chyshen@aiofm.ac.cn | |
| Website | http://www.hf.cas.cn/ |
"ROR" |
https://ror.org/046n57345 |
Hospital/treatment centre
678 Furong Road
Economic and Technological Development Zone
Hefei
230601
China
| Phone | +86 (0)551 63869420 |
|---|---|
| 512130761@qq.com | |
| Website | http://www.ay2fy.com/ |
|
"ROR" |
https://ror.org/047aw1y82 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- YIPA
- Location
- China
No information available
No information available
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- 安徽医科大学, AHMU
- Location
- China
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Chinese Academy of Sciences (xzou@cmpt.ac.cn). All raw data detected by mass spectrometry and clinical data that do not affect the privacy of participants can be obtained within 1 year after the relevant papers are published. All units and individuals interested in the experiment can obtain the experimental data for analyses without commercial interest by email consultation. The consent of the participant will be obtained and the participant's name and other private details will not be provided. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 24/11/2021 | No | No |
Additional files
Editorial Notes
26/11/2021: Internal review.
24/11/2021: Trial's existence confirmed by the Second Hospital of Anhui Medical University Ethics Committee.
