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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06338969
Other study ID # PostBariKetosis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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