An observational study in Diabetes Mellitus and Ketoacidosis, sponsored by St Vincent's Hospital Melbourne. Completed at 1 site in Australia. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by St Vincent's Hospital Melbourne · Observational
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.
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?
181 studies on the registry are indexed under Ketosis; 37 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 31 observational studies indexed under Ketosis.
Browse Ketosis studies →St Vincent's Hospital Melbourne is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
General surgery group, undergoing the following elective surgeries:
Bariatric surgery group, undergoing the following elective surgeries and a very low calorie diet before surgery:
Exclusion Criteria:
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.
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
Blood ketone
blood ketone levels
Time frame: 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.
Time frame: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St Vincent's Hospital Melbourne