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Trial registered on ANZCTR


Registration number
ACTRN12620000885998p
Ethics application status
Not yet submitted
Date submitted
2/06/2020
Date registered
7/09/2020
Date last updated
7/09/2020
Date data sharing statement initially provided
7/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Variations in the level of blood ketones in patients commenced on a very low-calorie diet before and after having weight loss reduction (bariatric) surgery
Scientific title
Variations in preoperative blood ketones in patients on a very low-calorie diet undergoing bariatric surgery
Secondary ID [1] 301429 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 317711 0
Condition category
Condition code
Diet and Nutrition 316542 316542 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enrolled participants will fall into one of three distinct groups: non-diabetic patients, patients with type 2 diabetes mellitus (T2DM) who are not taking SGLT2i medications, and T2DM patients who are taking SGLT2i medications.
Venous blood will be collected at 5 time points: 2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively.
The following will be measured: venous blood glucose, ketones, pH, bicarbonate and base excess.
Intervention code [1] 317740 0
Diagnosis / Prognosis
Comparator / control treatment
Non-diabetic patients will be the "reference comparator" group.
Control group
Active

Outcomes
Primary outcome [1] 324669 0
Venous blood ketone level
Timepoint [1] 324669 0
2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively
Primary outcome [2] 324670 0
Venous blood glucose level
Timepoint [2] 324670 0
2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively
Primary outcome [3] 324671 0

Venous blood pH level
Timepoint [3] 324671 0
2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively
Secondary outcome [1] 383522 0
Change in venous blood ketone level will be assessed
.
Timepoint [1] 383522 0
Venous blood ketone level will be measured will be performed at 5 time points: 2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively.
Secondary outcome [2] 385376 0
Venous blood bicarbonate level (primary outcome)
Timepoint [2] 385376 0
2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively
Secondary outcome [3] 385377 0
Venous blood base excess level (primary outcome)
Timepoint [3] 385377 0
2 weeks preoperatively (baseline), 1 week preoperatively, the day of surgery prior to commencement of anaesthesia, day 1 and day 2 post-operatively

Eligibility
Key inclusion criteria
-Consented adult patients who undergo all bariatric surgery at CRGH.
- Bariatric surgery defined as the following procedures: sleeve gastrectomy, single loop gastric bypass and gastric bypass Roux-en-Y
-Prescribed a very low carbohydrate diet (VLCD) commenced 2 weeks before surgery
-Non-diabetics patients
Type 2 diabetes mellitus (T2DM) on any treatment.
- Type 2 diabetes defined according to Australian Diabetes Society criteria: any of the following biochemical evidence of impaired glucose tolerance: HbA1c greater than or equal to 6.5% (48 mmol/mol), fasting glucose greater than or equal to 7.0 mmol/L, random glucose greater than or equal to 11.1 mmol/L, on a 75 g oral glucose tolerance test: fasting glucose greater than or equal to 7.0 mmol/L or 2 hr glucose greater than or equal to 11.1 mmol/L, or being treated for diabetes with any diet, oral hypoglycaemic agents or insulin regimen.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Type 1 diabetes mellitus

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We plan to recruit 250-300 patients.
Statistical analysis will be done in collaboration with a statistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16828 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 30451 0
2139 - Concord
Recruitment postcode(s) [2] 30452 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 305866 0
Hospital
Name [1] 305866 0
Concord Repatriation General Hospital
Country [1] 305866 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Area Health
Address
Concord Repatriation General Hospital
Hospital Road
Concord
NSW 2137
Country
Australia
Secondary sponsor category [1] 306316 0
None
Name [1] 306316 0
Address [1] 306316 0
Country [1] 306316 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306126 0
Human Research and Ethics Committe, Concord Repatriation General Hospital, Sydney Area Local Health Authority
Ethics committee address [1] 306126 0
Hospital Road
Concord
NSW 2137
Australia
Ethics committee country [1] 306126 0
Australia
Date submitted for ethics approval [1] 306126 0
05/11/2020
Approval date [1] 306126 0
Ethics approval number [1] 306126 0

Summary
Brief summary
This study aims to assess the change in blood ketones seen in patients prescribed a very low carbohydrate diet (VLCD)before bariatric surgery.
Patients on a VLCD have an increase in the blood levels of a chemical know as a"ketone'
The level of measured ketones is different in each patient.
Some diabetic medications can result in excessive levels of ketones in patients on VLCD.
This study will help understand changes in blood ketones in patients undergoing bariatric surgery who are on VLCD who may or may not be on diabetic medications
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102802 0
Dr Philip Corke
Address 102802 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Concord
NSW 2137
Country 102802 0
Australia
Phone 102802 0
+61 2 97676450
Fax 102802 0
Email 102802 0
[email protected]
Contact person for public queries
Name 102803 0
Dr Philip Corke
Address 102803 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Concord
NSW 2137
Country 102803 0
Australia
Phone 102803 0
+612 97676450
Fax 102803 0
Email 102803 0
[email protected]
Contact person for scientific queries
Name 102804 0
Dr Philip Corke
Address 102804 0
Department of Anaesthesia and Pain Management
Concord Repatriation General Hospital
Concord
NSW 2137
Country 102804 0
Australia
Phone 102804 0
+612 97676450
Fax 102804 0
Email 102804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.