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临床试验/NCT05442918
NCT05442918已完成不适用

Expected Normal Ketone Values After Very Low and Bariatric Surgery

St Vincent's Hospital Melbourne1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Blood ketone

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Blood ketone

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

blood ketone levels

Venous blood gas levels

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

Primary outcome measures are blood ketone, and venous blood gas levels.

次要结局

未报告次要终点

研究者

发起方
St Vincent's Hospital Melbourne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Hii

Doctor

St Vincent's Hospital Melbourne

研究点 (1)

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