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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | The time frame is baseline,1, 3, 6,12 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oral Ospanov, PhD | Contact | 7015287734 | +7 | bariatric.kz@gmail.com |
| Bakhtiyar Yelembayev | Contact | 7071302383 | +7 | elembaevbaha@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Oral Ospanov, PhD | The Society of Bariatric and Metabolic Surgeons of Kazakhstan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Ospanov | Recruiting | Astana | Aqmola | 010000 | Kazakhstan |
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|
|
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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