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

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338969
• Other study ID #: PostBariKetosis
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Contact: Oral Ospanov, PhD
• Phone: 7015287734
• Email: bariatric.kz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with active physical sports
• diabetes
• cirrhosis

Related Conditions & MeSH terms

• Acidosis
• Carbohydrate Metabolism Disorder
• Ketosis
• Metabolic Diseases
• NASH
• Obesity, Morbid

Intervention

Other:
• Carbohydrate Restriction after a Gastric Bypass
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.

Locations

Country	Name	City	State
Kazakhstan	Oral Ospanov	Astana	Aqmola

Sponsors (1)

Lead Sponsor	Collaborator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cases of ketosis and incidence of ketoacidosis	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	The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Primary	Cases of liver failure	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	The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Secondary	Change in body mass index (? BMI)	This measurement assesses the change in BMI after the intervention. Weight (kg) and height (cm) will be combined in the BMI (kg/m2).	The time frame is baseline,1, 3, 6,12 months after surgery.