Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338969
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-24
Brief Title:
The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis
Sponsor:
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Organization:
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None