Obesity, MorbidNCT06176443
Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass on Metabolic Outcomes Type 2 Diabetes.
A study testing One anastomosis gastric bypass with combined fundoplication and One anastomosis gastric bypass without combined fundoplication in people with Obesity, Morbid and Diabetes Mellitus, Type 2, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
Trial summary
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid, Diabetes Mellitus, Type 2
- What is being tested?
- One anastomosis gastric bypass with combined fundoplication and One anastomosis gastric bypass without combined fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteKazakhstan
- Study dates
- 13 Jan 2020to 1 May 2024
- 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
- BMI 25-55 kg/m2
- Patients with Diabetes Mellitus, Type 2
Who cannot join
- BMI <25 and >55 kg/m2
- Patients without Diabetes Mellitus, Type 2
- History of surgery on the stomach
- Less than 18 or more than 60 years of age
- Psychiatric illness
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass Using a "FundoRing" Fundoplication on Metabolic Outcomes in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
Read the detailed description
The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.
The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.
- Conditions
- Obesity, Morbid, Diabetes Mellitus, Type 2
- Being tested
- One anastomosis gastric bypass with combined fundoplication, One anastomosis gastric bypass without combined fundoplication
- Keywords
- Obesity, Metabolic Surgery, FundoRing, One anastomosis gastric bypass, Fundoplication, Diabetes Mellitus, Type 2
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One anastomosis gastric bypass with combined fundoplicationProcedure or surgery
FundoRingOAGB
One anastomosis gastric bypass without combined fundoplicationProcedure or surgery
OAGB
| Study group | Role | What they receive |
|---|---|---|
| One anastomosis gastric bypass with combined fundoplication | Experimental | One anastomosis gastric bypass with combined fundoplication "FundoRing" Receives: Procedure: One anastomosis gastric bypass with combined fundoplication |
| One anastomosis gastric bypass without combined fundoplication | Active comparator | One anastomosis gastric bypass without combined fundoplication Receives: Procedure: One anastomosis gastric bypass without combined fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic improvements of type 2 diabetes
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
Measured: Baseline, at 12, 24, 36 months after surgery
Secondary outcomes (1)
Change of body mass index
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2
Measured: Baseline, at 12, 24, 36 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 posted19 Dec 2023
- Study start13 Jan 2020
- Primary completion13 Jan 2024
- Study completion1 May 2024
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
- 300 participants (actual)
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, Professor, Principal investigator, Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176443
- Sponsor's protocol ID
- 2_DM_F.R. 2020_2024
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass Using a "FundoRing" Fundoplication on Metabolic Outcomes in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06176443
- Acronym / sponsor ID
- 2_DM_F.R. 2020_2024
- Conditions
- Obesity, Morbid, Diabetes Mellitus, Type 2
- Keywords
- Obesity, Metabolic Surgery, FundoRing, One anastomosis gastric bypass, Fundoplication, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Dec 2023 (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.
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
Detailed description
The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.
The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.
The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One anastomosis gastric bypass with combined fundoplication | Experimental | Procedure: One anastomosis gastric bypass with combined fundoplicationOne anastomosis gastric bypass with combined fundoplication "FundoRing" |
| One anastomosis gastric bypass without combined fundoplication | Active comparator | Procedure: One anastomosis gastric bypass without combined fundoplicationOne anastomosis gastric bypass without combined fundoplication |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 25-55 kg/m2
- Patients with Diabetes Mellitus, Type 2
Key exclusion criteria (6 listed)
- BMI <25 and >55 kg/m2
- Patients without Diabetes Mellitus, Type 2
- History of surgery on the stomach
- Less than 18 or more than 60 years of age
- Psychiatric illness
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 |
|---|---|---|
| One anastomosis gastric bypass with combined fundoplicationFundoRingOAGB | Procedure or surgery | One anastomosis gastric bypass with combined fundoplication |
| One anastomosis gastric bypass without combined fundoplicationOAGB | Procedure or surgery | One anastomosis gastric bypass without combined fundoplication |
Primary outcome
Metabolic improvements of type 2 diabetes
Time frame: Baseline, at 12, 24, 36 months after surgery
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
1 secondary outcome
Change of body mass index
Time frame: Baseline, at 12, 24, 36 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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, Professor principal investigator
Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One anastomosis gastric bypass with combined fundoplication and One anastomosis gastric bypass without combined fundoplication in people with Obesity, Morbid and Diabetes Mellitus, Type 2, 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 6 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: finished, as of the sponsor's last update on 21 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic improvements of type 2 diabetes (time frame: Baseline, at 12, 24, 36 months after surgery). 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 21 Nov 2024.