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

Variations in preoperative blood ketones in patients on a very low-calorie diet undergoing bariatric surgery

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000885998

Enrollment

250

Registered

2020-09-07

Start date

2021-01-01

Completion date

2021-12-01

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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, bicarbo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

Exclusion criteria

Patients with Type 1 diabetes mellitus

Outcome results