An interventional study of Carbohydrate Restriction after a Gastric Bypass in Obesity, Morbid, NASH and Ketosis, sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan · Not applicable, Interventional, and Treatment
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.
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 150 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →The Society of Bariatric and Metabolic Surgeons of Kazakhstan is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Also known as: laparoscopic one anastomotic gastric bypass
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
Time frame: 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
Time frame: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
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).
Time frame: The time frame is baseline,1, 3, 6,12 months after surgery.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Apr 2025, 12 months after the start.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
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The Society of Bariatric and Metabolic Surgeons of Kazakhstan