The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Status: Enrolling

Conditions: NASH; Carbohydrate Metabolism Disorder; Ketosis; Keto Acidosis; Obesity, Morbid

Treatments: Other: Carbohydrate Restriction after a Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT06338969

PostBariKetosis

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• obesity patients BMI 30-50 kg/m2.
• patients with nonalcoholic steatohepatitis (NASH).

Exclusion criteria

• patients with active physical sports
• diabetes
• cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates

Experimental group

Description:

In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit of 51-75%.

Treatment:

Other: Carbohydrate Restriction after a Gastric Bypass

Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates

Active Comparator group

Description:

In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit: 26-50% deficit in carbohydrates.

Treatment:

Other: Carbohydrate Restriction after a Gastric Bypass

Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates

Active Comparator group

Description:

In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit:1-25% deficit in carbohydrates.

Treatment:

Other: Carbohydrate Restriction after a Gastric Bypass