Laboratory evaluation of β-hydroxybutyrate levels in capillary and venous blood
| ISRCTN | ISRCTN31042751 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31042751 |
| IRAS number | 275338 |
| Secondary identifying numbers | ADC-UK-RES-19045; IRAS 275338 |
- Submission date
- 13/12/2019
- Registration date
- 20/12/2019
- Last edited
- 21/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes mellitus. DKA is typically diagnosed when testing finds high blood sugar, low blood pH and ketones (including β-hydroxybutyrate) in either the blood or urine. Ketones are substances that your body makes if your cells don't get enough glucose (blood sugar).
The aim of this study is to evaluate the difference between blood β-hydroxybutyrate levels in blood that is flowing away from the heart and flowing towards the heart (after it has passed through tissues).
Who can participate?
Patients aged 16 and over who are potentially ketotic.
What does the study involve?
The participant will give a blood sample by venepuncture (the puncture of a vein) or by a fingerprick and the blood will be tested on the reference method as plasma.
Participants can give a maximum of four blood samples until ketone levels return to normal. Participation in this study will cease prior to hospital discharge.
What are the possible benefits & risks of participating?
There is no direct benefit to the participant taking part in this study. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
1. John Radcliffe Hospital, Oxford, UK
2. Royal Surrey County Hospital, Guildford, UK
3. Royal United Hospitals, Bath, UK
4. Royal Cornwall Hospital, Truro, UK
5. Royal Infirmary, Edinburgh, UK
When is the study starting and how long is it expected to run for?
September 2019 to September 2020
Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd, USA
Who is the main contact?
Dr Pamela Reid
Pamela.Reid@abbott.com
Contact information
Public
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| Pamela.Reid@abbott.com |
Study information
| Study design | Prospective multi-centre single-arm study in hospital settings |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Laboratory evaluation of β-hydroxybutyrate levels in capillary and venous blood |
| Study objectives | This study is being conducted to determine the difference in β-hydroxybutyrate levels in capillary and venous blood, sampled concurrently from people in diabetic ketoacidosis (DKA) or with ketosis. |
| Ethics approval(s) | Approved 26/11/2019, NRES Committee: London - City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8033; nrescommittee.london-cityandeast@nhs.net), ref: 19/LO/1919 |
| Health condition(s) or problem(s) studied | Diabetic ketoacidosis or ketosis |
| Intervention | Participants will have venous and capillary blood collected, which may be repeated: - A maximum of 4 times - Or, until ketone levels return to normal - Or, participants are discharged from hospital |
| Intervention type | Other |
| Primary outcome measure | Capillary blood β-hydroxybutyrate levels and venous blood β-hydroxybutyrate levels as measured on the Randox Ranbut laboratory reference method using Bland-Altman analysis at each visit |
| Secondary outcome measures | None |
| Overall study start date | 01/09/2019 |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35 |
| Key inclusion criteria | 1. Aged 16 years or over 2. Potentially ketotic, or in diabetic ketoacidosis |
| Key exclusion criteria | 1. Already participated in this study 2. Concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff 3. Infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C), or human immunodeficiency virus (HIV) |
| Date of first enrolment | 06/01/2020 |
| Date of final enrolment | 30/09/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
OX3 9DU
United Kingdom
GU2 7XX
United Kingdom
BA1 3NG
United Kingdom
TR1 3LJ
United Kingdom
EH16 4TJ
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
| Phone | +44 (0)1993 863024 |
|---|---|
| Pamela.Reid@abbott.com | |
| Website | http://www.abbott.co.uk/ |
"ROR" |
https://ror.org/03wnay029 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. Estimated timeline is one year from trial end date. |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be available upon request from Pamela Reid (Pamela.Reid@abbott.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 21/11/2024 | No | No |
Additional files
Editorial Notes
21/11/2024: The basic results have been uploaded as an additional file.
27/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2020 to 30/09/2020.
2. The overall end date was changed from 31/08/2020 to 30/09/2020.
3. The intention to publish date was changed from 31/08/2021 to
4. The plain English summary was updated to reflect these changes.
08/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 31/08/2020.
2. The overall end date was changed from 30/06/2020 to 31/08/2020.
3. The intention to publish date was changed from 30/06/2021 to 31/08/2021.
4. The plain English summary was updated to reflect these changes.
07/04/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 30/06/2020.
2. The overall end date was changed from 31/03/2020 to 30/06/2020.
3. The intention to publish date was changed from 31/03/2021 to 30/06/2021.
4. The plain English summary was updated to reflect these changes.
12/03/2020: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2020 to 31/03/2020.
2. The overall trial end date has been changed from 28/02/2020 to 31/03/2020.
3. The intention to publish date has been changed from 28/02/2021 to 31/03/2021.
4. The plain English summary has been updated to reflect the changes above.
19/12/2019: Trial's existence confirmed by London - City & East Research Ethics Committee.
