The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Manifestation of Starvation Ketosis and Ketoacidosis in Patients With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cases of ketosis and incidence of ketoacidosis
研究概览
简要总结
Background:
Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.
Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).
The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.
Objectives:
The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year.
详细描述
Methods:
This study is a three-arm randomized controlled trial. All patients will undergo laparoscopic one anastomotic gastric bypass. In the postoperative period, all patients will receive normal daily amounts of protein and fat. Depending on the amount of carbohydrates that will be received after surgery, patients will randomly (no mask) be divided into three groups:
The first group: 51-75% deficit in carbohydrates Second group: 26-50% deficit in carbohydrates The third group: has a 1-25% deficit in carbohydrates.
Primary outcome measurement Compare the incidence of ketoacidosis and liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass.
Secondary outcome measurements Change in body mass index (Δ BMI). Effect weight loss for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity patients BMI 30-50 kg/m
- •patients with nonalcoholic steatohepatitis (NASH).
排除标准
- •patients with active physical sports
- •cirrhosis
结局指标
主要结局
Cases of ketosis and incidence of ketoacidosis
时间窗: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Compare the incidence of ketoacidosis and liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass
Cases of liver failure
时间窗: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Compare the incidence of liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass
次要结局
- Change in body mass index (Δ BMI)(The time frame is baseline,1, 3, 6,12 months after surgery.)