Diabetes MellitusNCT05442918
Expected Normal Ketone Values After Very Low and Bariatric Surgery
An observational study of Diabetes Mellitus and Ketoacidosis, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial summary
The investigators propose a multicenter prospective study in patients undergoing either an elective bariatric procedure or an elective benign procedure, including laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Ketoacidosis
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jan 2020to 12 Dec 2020
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing either elective laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair or elective bariatric procedure will be recruited consecutively. Those in the bariatric arm must have been on a VLCD pre operatively. Recruitment does not require blinding or randomization. Patients will be excluded if they are non-English speaking or cannot consent to the project, if they are already taking an SLGT2 inhibitor or if their procedure was abandoned.
Who may be able to join
- General surgery group, undergoing the following elective surgeries:
- laparoscopic/open cholecystectomy
- laparoscopic/open hiatus hernia repair
- laparoscopic/open inguinal hernia repair
- laparoscopic/open umbilical hernia repair
- laparoscopic ventral wall hernia repair
Show all 9Show fewer
- Bariatric surgery group, undergoing the following elective surgeries and a very low calorie diet before surgery:
- laparoscopic sleeve gastrectomy
- laparoscopic roux-en-y gastric bypass
Who cannot join
- currently on SLGT2 inhibitor
- non English speaking
- procedure abandoned
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a multicenter prospective study in patients undergoing either an elective bariatric procedure or an elective benign procedure, including laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. Perioperative blood ketone and venous blood gas levels will be measured pre-surgery, post-surgery and on post-operative days until discharge.
Our primary research objective is to clarify the expected perioperative ketone and blood gas levels in elective bariatric patients who have been on a VLCD and fasting for surgery, compared to elective surgical patients who have only been fasting prior to surgery.
Read the detailed description
Bariatric surgery is fast becoming a mainstream option for achieving long-term weight loss in the morbidly obese population due to the paucity of other effective alternatives. It is indicated in those with a Body Mass Index (BMI) >40, or those with an obesity-related comorbidity with a BMI >35. One of the most common of these comorbidities is Type 2 Diabetes Mellitus (T2DM).
In the weeks preceding bariatric surgery, it is routine for patients to be placed on a very low calorie diet (VLCD). The aim is to reduce abdominal wall thickness, visceral adiposity and hepatomegaly. Overall, this contributes to reduced technical difficulties at operation.
VLCD achieve rapid weight loss in the short term by inducing ketosis. This is achieved by reducing the consumption of carbohydrate and fat, while increasing protein intake. The depletion of caloric intake leads to decreased glucose stores. This then leads to a metabolic shift towards production of ketone bodies, which are produced by the liver via the oxidation of fatty acids. Ketones are then transported to tissue to take over the role of glucose as the main energy source for the central nervous system. The objective is to reduce fat mass without causing excess loss of muscle mass.
Overall the VLCD regime, via the induction of ketosis, is very successful in weight reduction. However this mechanism of action, and the production of ketone bodies, is now being questioned in those prescribed a new class of glucose lowering medication used to treat T2DM.
Sodium-glucose co-transporter-2 (SGLT2) inhibitors, also called gliflozins, are medications that reduce absorption of glucose in the kidney thus increasing excretion via urine. Phase 3 trials have shown them to be safe for treatment of T2DM however; however concern has been raised about development of a euglycaemic diabetic ketoacidosis. It is thought to occur when stress hormones lead to increased ketosis in patients taking SGLT2 inhibitors, which appear to alter insulin production. This situation can occur in the perioperative period if the SGLT2 inhibitors have not been correctly withheld pre-operatively.
Current guidelines from the Australian and New Zealand College of Anaesthetists recommend the cessation of SLGT2 inhibitors 3 days prior to surgery. If this has not occurred, they state blood ketones should be tested. If the blood ketones are >0.6, it is a strong recommendation to postpone non-urgent surgery. Ketone and base excess levels are then used to monitor patients in the perioperative period.
The confounding factor in these patients now presents itself- what are the expected blood ketone levels in bariatric patients who have been on two week of pre-operative VLCD and are fasting for surgery?
- Conditions
- Diabetes Mellitus, Ketoacidosis
- Medical subject headings
- Diabetes Mellitus, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Surgery | All patients undergoing either elective laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. | |
| Bariatric Surgery | Participants undergoing elective bariatric surgery (laparoscopic sleeve gastrectomy or roux-en-y gastric bypass). Those in the bariatric arm must have been on a VLCD pre operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood ketone
blood ketone levels
Measured: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
Venous blood gas levels
Primary outcome measures are blood ketone, and venous blood gas levels.
Measured: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Jan 2020
- Primary completion11 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hii, St Vincent's Hospital Melbourne
- Investigators
- Michael Hii, FRACS, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442918
- Sponsor's protocol ID
- StVincentsMelbourne
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mollah T, Gillespie C, Cocco A, Taylor L, Chong L, Hii MW. Defining Physiological Ketosis Following Very-Low-Calorie Diets. J Surg Res. 2023 Oct;290:197-202. doi: 10.1016/j.jss.2023.05.001. Epub 2023 Jun 2.
PubMed 37271067
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expected Normal Ketone Values After Very Low and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05442918
- Acronym / sponsor ID
- StVincentsMelbourne
- Conditions
- Diabetes Mellitus, Ketoacidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 5 Jul 2022 (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.
The investigators propose a multicenter prospective study in patients undergoing either an elective bariatric procedure or an elective benign procedure, including laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. Perioperative blood ketone and venous blood gas levels will be measured pre-surgery, post-surgery and on post-operative days until discharge.
Our primary research objective is to clarify the expected perioperative ketone and blood gas levels in elective bariatric patients who have been on a VLCD and fasting for surgery, compared to elective surgical patients who have only been fasting prior to surgery.
Detailed description
Bariatric surgery is fast becoming a mainstream option for achieving long-term weight loss in the morbidly obese population due to the paucity of other effective alternatives. It is indicated in those with a Body Mass Index (BMI) >40, or those with an obesity-related comorbidity with a BMI >35. One of the most common of these comorbidities is Type 2 Diabetes Mellitus (T2DM).
In the weeks preceding bariatric surgery, it is routine for patients to be placed on a very low calorie diet (VLCD). The aim is to reduce abdominal wall thickness, visceral adiposity and hepatomegaly. Overall, this contributes to reduced technical difficulties at operation.
VLCD achieve rapid weight loss in the short term by inducing ketosis. This is achieved by reducing the consumption of carbohydrate and fat, while increasing protein intake. The depletion of caloric intake leads to decreased glucose stores. This then leads to a metabolic shift towards production of ketone bodies, which are produced by the liver via the oxidation of fatty acids. Ketones are then transported to tissue to take over the role of glucose as the main energy source for the central nervous system. The objective is to reduce fat mass without causing excess loss of muscle mass.
Overall the VLCD regime, via the induction of ketosis, is very successful in weight reduction. However this mechanism of action, and the production of ketone bodies, is now being questioned in those prescribed a new class of glucose lowering medication used to treat T2DM.
Sodium-glucose co-transporter-2 (SGLT2) inhibitors, also called gliflozins, are medications that reduce absorption of glucose in the kidney thus increasing excretion via urine. Phase 3 trials have shown them to be safe for treatment of T2DM however; however concern has been raised about development of a euglycaemic diabetic ketoacidosis. It is thought to occur when stress hormones lead to increased ketosis in patients taking SGLT2 inhibitors, which appear to alter insulin production. This situation can occur in the perioperative period if the SGLT2 inhibitors have not been correctly withheld pre-operatively.
Current guidelines from the Australian and New Zealand College of Anaesthetists recommend the cessation of SLGT2 inhibitors 3 days prior to surgery. If this has not occurred, they state blood ketones should be tested. If the blood ketones are >0.6, it is a strong recommendation to postpone non-urgent surgery. Ketone and base excess levels are then used to monitor patients in the perioperative period.
The confounding factor in these patients now presents itself- what are the expected blood ketone levels in bariatric patients who have been on two week of pre-operative VLCD and are fasting for surgery?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Surgery | – | –All patients undergoing either elective laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. |
| Bariatric Surgery | – | –Participants undergoing elective bariatric surgery (laparoscopic sleeve gastrectomy or roux-en-y gastric bypass). Those in the bariatric arm must have been on a VLCD pre operatively |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing either elective laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair or elective bariatric procedure will be recruited consecutively. Those in the bariatric arm must have been on a VLCD pre operatively. Recruitment does not require blinding or randomization. Patients will be excluded if they are non-English speaking or cannot consent to the project, if they are already taking an SLGT2 inhibitor or if their procedure was abandoned.
Key inclusion criteria (9 listed)
- laparoscopic/open cholecystectomy
- laparoscopic/open hiatus hernia repair
- laparoscopic/open inguinal hernia repair
- laparoscopic/open umbilical hernia repair
- laparoscopic ventral wall hernia repair
Key exclusion criteria (3 listed)
- currently on SLGT2 inhibitor
- non English speaking
- procedure abandoned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood ketone
Time frame: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
blood ketone levels
Venous blood gas levels
Time frame: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
Primary outcome measures are blood ketone, and venous blood gas levels.
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 5 Jul 2022.
- Derived from this study: PubMed 37271067Mollah T, Gillespie C, Cocco A, Taylor L, Chong L, Hii MW. Defining Physiological Ketosis Following Very-Low-Calorie Diets. J Surg Res. 2023 Oct;290:197-202. doi: 10.1016/j.jss.2023.05.001. Epub 2023 Jun 2.
- Individual participant dataSharing planned: Undecided
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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.
Michael Hii, FRACS principal investigator
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Ketoacidosis, run by St Vincent's Hospital Melbourne at 1 site in Australia.
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 9 inclusion and 3 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 5 Jul 2022. 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 Australia. 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?
Blood ketone (time frame: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week). The study lists 2 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 NCT05442918, which also lists 1 linked publication.
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 5 Jul 2022.