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CompletedNCT05442918Updated Jul 5, 2022

Expected Normal Ketone Values After Very Low and Bariatric Surgery

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

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
55
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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?

02

Conditions studied

  • Diabetes Mellitus
  • Ketoacidosis

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03

In context

Ketosis

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.

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Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

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

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

Exclusion criteria

Exclusion Criteria:

  • currently on SLGT2 inhibitor
  • non English speaking
  • procedure abandoned
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Blood ketone

    blood ketone levels

    Time frame: Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week

  2. 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

07

Study locations

1 site
  • St Vincent's Hospital Melbourne
    Fitzroy, Victoria 3065, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05442918
Lead sponsor
St Vincent's Hospital Melbourne
Responsible party
Michael Hii (Doctor, St Vincent's Hospital Melbourne) — Principal investigator
First posted
Jul 5, 2022
Start date
Jan 15, 2020
Primary completion
Dec 11, 2020
Completion
Dec 12, 2020
Last update
Jul 5, 2022

Study contacts

Michael Hii, FRACS
principal investigator · St Vincent's Hospital Melbourne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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