Clinical trial NCT06338969: The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis
Official title: The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Manifestation of Starvation Ketosis and Ketoacidosis in Patients With Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
NASH
Ketosis
Keto Acidosis
Carbohydrate Metabolism Disorder
Keywords: Carbohydrate restriction
Ketosis after bariatric surgery
Lead sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with active physical sports
* diabetes
* cirrhosis

Primary outcomes:
measure: Cases of ketosis and incidence of ketoacidosis
timeFrame: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
measure: Cases of liver failure
timeFrame: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Secondary outcomes:
measure: Change in body mass index (Δ BMI)
timeFrame: The time frame is baseline,1, 3, 6,12 months after surgery.
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Oral Ospanov
state: Aqmola
Study officials:
affiliation: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
name: Oral Ospanov, PhD
role: PRINCIPAL_INVESTIGATOR
References: