Obesity, MorbidNCT06338969
The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis
A study testing Carbohydrate Restriction after a Gastric Bypass in people with Obesity, Morbid and NASH, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid, NASH, Ketosis
- What is being tested?
- Carbohydrate Restriction after a Gastric Bypass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteKazakhstan
- Study dates
- 25 Mar 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obesity patients BMI 30-50 kg/m2.
- patients with nonalcoholic steatohepatitis (NASH).
Who cannot join
- patients with active physical sports
- diabetes
- cirrhosis
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Oral Ospanov
Astana, Aqmola, 010000
Oral Ospanov, PhD, 7015287734 ext. +7, bariatric.kz@gmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Obesity, Morbid, NASH, Ketosis, Keto Acidosis, Carbohydrate Metabolism Disorder
- Being tested
- Carbohydrate Restriction after a Gastric Bypass
- Keywords
- Carbohydrate restriction, Ketosis after bariatric surgery
- Medical subject headings
- Obesity, Morbid, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Restriction after a Gastric BypassOther
Also called laparoscopic one anastomotic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Other: Carbohydrate Restriction after a Gastric Bypass |
| 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. Receives: Other: Carbohydrate Restriction after a Gastric Bypass |
| 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. Receives: Other: Carbohydrate Restriction after a Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.
Secondary outcomes (1)
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).
Measured: The time frame is baseline,1, 3, 6,12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start25 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oral Ospanov, PhD, Principal investigator, The Society of Bariatric and Metabolic Surgeons of Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338969
- Sponsor's protocol ID
- PostBariKetosis
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06338969
- Acronym / sponsor ID
- PostBariKetosis
- Conditions
- Obesity, Morbid, NASH, Ketosis, Keto Acidosis, Carbohydrate Metabolism Disorder
- Keywords
- Carbohydrate restriction, Ketosis after bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates | Experimental | Other: Carbohydrate Restriction after a Gastric BypassIn 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 | Other: Carbohydrate Restriction after a Gastric BypassIn 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 | Other: Carbohydrate Restriction after a Gastric BypassIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obesity patients BMI 30-50 kg/m2.
- patients with nonalcoholic steatohepatitis (NASH).
Key exclusion criteria (3 listed)
- patients with active physical sports
- diabetes
- cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate Restriction after a Gastric BypassAlso: laparoscopic one anastomotic gastric bypassAll 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. | Other | Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates, Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates, Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates |
Primary outcome
Cases of ketosis and incidence of ketoacidosis
Time frame: 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
Cases of liver failure
Time frame: 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
1 secondary outcome
Change in body mass index (Δ BMI)
Time frame: The time frame is baseline,1, 3, 6,12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oral Ospanov, PhD principal investigator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Restriction after a Gastric Bypass in people with Obesity, Morbid and NASH, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oral Ospanov, PhD (7015287734 ext. +7, bariatric.kz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cases of ketosis and incidence of ketoacidosis (time frame: The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.