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

The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Manifestation of Starvation Ketosis and Ketoacidosis in Patients With Nonalcoholic Steatohepatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Ketosis; NASH; Keto Acidosis; Carbohydrate Metabolism Disorder
• Intervention / Treatment: Other: Carbohydrate Restriction after a Gastric Bypass

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oral Ospanov, PhD; Phone Number: +7 7015287734; Email: bariatric.kz@gmail.com
• Study Contact Backup: Name: Bakhtiyar Yelembayev; Phone Number: +7 7071302383; Email: elembaevbaha@gmail.com

Study Locations

• Kazakhstan
  • Aqmola
    • Astana, Aqmola, Kazakhstan, 010000
      • Recruiting
      • Oral Ospanov
      • Contact: Oral Ospanov, PhD; Phone Number: +7 7015287734; Email: bariatric.kz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients with active physical sports
• diabetes
• cirrhosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates; 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%.	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.; Other Names: laparoscopic one anastomotic gastric bypass
Active Comparator: Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates; 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.	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.; Other Names: laparoscopic one anastomotic gastric bypass
Active Comparator: Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates; 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.	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.; Other Names: laparoscopic one anastomotic gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index (Δ 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.

Collaborators and Investigators

• Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Investigators: Principal Investigator: Oral Ospanov, PhD, The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Carbohydrate restriction; Ketosis after bariatric surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Acid-Base Imbalance; Obesity, Morbid; Metabolic Diseases; Acidosis; Ketosis
• Other Study ID Numbers: PostBariKetosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No