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Development of a non-invasive and accurate diagnostic method for type 2 diabetes using acetone in urine samples

Non-invasive and accurate diagnosis of type 2 diabetes using urinary acetone: a prospective multicenter study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12308193
Enrollment
400
Registered
2021-11-25
Start date
2021-04-20
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

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.

Sponsors

Hefei Institutes of Physical Science
Lead Sponsor
Second Hospital of Anhui Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Urinary acetone is measured using proton transfer reaction mass spectrometry in less than 8 h after sampling

Secondary

MeasureTime frame
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

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026