Carbohydrate Metabolism Disorder, Keto Acidosis, Ketosis, NASH, Obesity, Morbid
Conditions
Keywords
Carbohydrate restriction, Ketosis after bariatric surgery
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.
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.
Interventions
OTHERCarbohydrate 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.
Sponsors
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* obesity patients BMI 30-50 kg/m2. * patients with nonalcoholic steatohepatitis (NASH).
Exclusion criteria
* patients with active physical sports * diabetes * cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cases of liver failure | The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery. | 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 |
| Cases of ketosis and incidence of ketoacidosis | The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index (Δ BMI) | The time frame is baseline,1, 3, 6,12 months after surgery. | This measurement assesses the change in BMI after the intervention. Weight (kg) and height (cm) will be combined in the BMI (kg/m2). |
Countries
Kazakhstan
Contacts
Primary ContactOral Ospanov, PhD
Backup ContactBakhtiyar Yelembayev
Outcome results
None listed