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

NCT06338969 | Recruiting

• 1 other identifier: PostBariKetosis
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Carbohydrate restriction; Ketosis after bariatric surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in body mass index (Δ BMI)

  The time frame is baseline,1, 3, 6,12 months after surgery.

Study Arms (3)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

Carbohydrate Restriction after a Gastric Bypass OTHER

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.

Also known as: laparoscopic one anastomotic gastric bypass

Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates; Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates; Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• patients with active physical sports
• diabetes
• cirrhosis

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan: lead

Study Sites (1)

Oral Ospanov

Astana, Aqmola, 010000, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Ketosis

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases

Study Officials

• Oral Ospanov, PhD

  The Society of Bariatric and Metabolic Surgeons of Kazakhstan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oral Ospanov, PhD

CONTACT

7015287734; bariatric.kz@gmail.com

Bakhtiyar Yelembayev

CONTACT

7071302383; elembaevbaha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: March 25, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)