Impact of Carbohydrate Restriction After Gastric Bypass on Ketosis and Ketoacidosis
The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Manifestation of Starvation Ketosis and Ketoacidosis in Patients With Nonalcoholic Steatohepatitis
This study is testing how different amounts of carbohydrates after gastric bypass surgery affect the risk of ketoacidosis and liver health in people with nonalcoholic steatohepatitis (NASH).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Society of Bariatric and Metabolic Surgeons of Kazakhstan Academic / other |
| Locations | 1 site (Astana, Aqmola) |
| Trial ID | NCT06338969 on ClinicalTrials.gov |
What this trial studies
This study investigates how different levels of carbohydrate restriction after gastric bypass surgery affect ketosis and the risk of ketoacidosis in patients with nonalcoholic steatohepatitis (NASH). It is a three-arm randomized controlled trial where participants will be assigned to receive varying amounts of carbohydrates post-surgery. The primary goal is to compare the incidence of ketoacidosis and liver failure among the groups, while secondary outcomes include changes in body mass index over one year. The study aims to provide insights into optimal dietary management for weight loss and metabolic health following bariatric surgery.
Who should consider this trial
Good fit: Ideal candidates are obese patients with a BMI between 30-50 kg/m2 who also have nonalcoholic steatohepatitis (NASH).
Not a fit: Patients with active physical sports, diabetes, or cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize dietary guidelines for post-bariatric surgery patients, improving weight loss outcomes and reducing the risk of ketoacidosis.
How similar studies have performed: While there is ongoing research into carbohydrate restriction and its effects post-bariatric surgery, this specific approach focusing on NASH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * obesity patients BMI 30-50 kg/m2. * patients with nonalcoholic steatohepatitis (NASH). Exclusion Criteria: * patients with active physical sports * diabetes * cirrhosis
Where this trial is running
Astana, Aqmola
- Oral Ospanov — Astana, Aqmola, Kazakhstan (Recruiting)
Study contacts
- Principal investigator: Oral Ospanov, PhD — The Society of Bariatric and Metabolic Surgeons of Kazakhstan
- Study coordinator: Oral Ospanov, PhD
- Email: bariatric.kz@gmail.com
- Phone: 7015287734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.