Expected Normal Ketone Values After Very Low and Bariatric Surgery

NCT05442918 | Completed

• 1 other identifier: StVincentsMelbourne
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Ketoacidosis

Outcome Measures

Primary Outcomes (2)

• Blood ketone

  blood ketone levels

  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.

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead

Study Sites (1)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Related Publications (1)

• 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.

  PMID: 37271067 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Ketosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance

Study Officials

• Michael Hii, FRACS

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 5, 2022
• Study Start: January 15, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 12, 2020
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

AU (1)