Incretin Hormones Plasma LevelsNCT07475143
A Comparative Study Between Effect Of Mini-gastric Bypass and Single Anastmosis Sleeve Jujenal Bypass On Levels Of GLP-1, GIP, PYY, Insulin Resistance and Type II DM Resolution
A study testing Single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass in people with Incretin Hormones Plasma Levels and Gastric Bypass Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Incretin Hormones Plasma Levels, Gastric Bypass Surgery
- What is being tested?
- Single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 15 Mar 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
- Patients age from 18 to 60 years old.
- Both sexes.
- Patients with BMI ≥ 35 with Type II diabetes mellitus.
Who cannot join
- Patients underwent previous Bariatric surgeries.
- Patients with severe systemic disease (ASA 4), such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago.
- Patients who refuse to participate in the study.
- Patients with psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Anastomosis Sleeve Jejunal Bypass VS One Anastomosis/Mini Gastric Bypass as Regards GLP-1, PYY, GIP, Insulin Resistance and Type II Diabetes Mellitus Resolution: A Prospective Partially Randomized Patient Preference Comparative Trial
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
Read the detailed description
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 (as a primary outcome), PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
SASJ Group: composed of 20 patients undergoing SASJ operation. - OAGB Group: composed of 20 patients undergoing OAGB operation.
Convenience sampling was used and the sample size was 40 patients. An informed consent was taken from all patients and all data are confidential, and patients will not be mentioned by name in any published paper. Patients will have the right to refuse joining the research or withdraw at any time without affecting their chance to receive the traditional therapy at any time.
Regarding the Study Procedures, all patients will have preoperative workup including full history taking, general and local examination, laboratory profile including complete blood picture, liver function tests, kidney function tests, clotting profile, fasting and 2-hour postprandial blood glucose, HbA1C, serum insulin level, C-peptide (in non-insulin receiving patients) and Viral markers. Also Serum levels of GLP-1, PYY and GIP, thyroid profile (Free T3, T4 and TSH), pelviabdominal US, and upper GI endoscopy in patients with GERD or when an intra-gastric pathology is suspected. Cardiopulmonary assessment could be done if clinically indicated.
Operative details - One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. A transverse anastomosis is usually done.
Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigators will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus.
Regarding postoperative follow up, routine follow up visits will be arranged after one month, 3 months and 6 months. Also serum levels of GLP-1, PYY and GIP will be measured 6-8 weeks post-operative. In each visit patient will have full clinical assessment including glycemic control especially HbA1c levels, fasting blood glucose levels, post prandial serum glucose levels, serum insulin levels, C peptide levels (in non-insulin receiving patients), weight loss rate and total weight loss percentage calculated with nutritional parameters like serum calcium, iron, albumin, vitamin D and PTH will be assessed once after 6 months.
- Being tested
- Single anastomosis sleeve jejunal bypass, One anastomosis gastric bypass
- Keywords
- SASJ, OAGB, GLP-1, GIP, PYY, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single anastomosis sleeve jejunal bypassProcedure or surgery
Also called SASJ
Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigator will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus.
One anastomosis gastric bypassProcedure or surgery
Also called OAGB, MGB, Mini-gastric Bypass
One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot.
| Study group | Role | What they receive |
|---|---|---|
| SASJ Group | Active comparator | Group of patients undergoing Single Anastomosis Sleeve Jejunal Bypass Receives: Procedure: Single anastomosis sleeve jejunal bypass |
| OAGB Group | Active comparator | Group of patients undergoing One Anastomosis Gastric Bypass Receives: Procedure: One anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit.
Plasma levels of Incretin GLP-1 are measured before and after the assigned operation using ELISA kits.GLP-1 levels will be measured using (pmol/L) unit.
Measured: Serum levels of GLP-1 will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.
Secondary outcomes (6)
Determine the change in plasma levels GIP after the assigned operation. Serum levels will be measured using (pmol/L) unit.
Plasma levels of Incretin GIP are measured before and after the assigned operation using ELISA kits.GIP levels will be measured using (pmol/L) unit.
Serum levels of GIP will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.
Measured: 6-8 weeks post operative
Determine the change in plasma levels Peptide-YY (PYY) after the assigned operation. Serum levels will be measured using (pmol/L) unit.
Plasma levels of Incretin PYY are measured before and after the assigned operation using ELISA kits. Serum levels will be measured using (pmol/L) unit.
Serum levels of PYY will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.
Measured: 6-8 weeks post operative
Total weight loss percentage
Measurement of total weight loss percentage (TWL%) 6-8 weeks post operative.
Measured: 6-8 weeks post operative
Glycemic control (Fasting)
Full clinical assessment including fasting blood glucose levels in mg/dL
Measured: 6-8 weeks post operative
Glycemic control (Postprandial)
Full clinical assessment including 2 hour post-prandial blood glucose levels in mg/dL.
Measured: 6-8 weeks post operative
Type II DM resolution
Blood HbA1c levels in percentage
Measured: 6-8 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incretin Hormones Plasma LevelsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Partially Randomized Patient Preference Comparative Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohey Eldin R ElBanna, Professor of General Surgery, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475143
- Sponsor's protocol ID
- 10/2024
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2025
- Last updated
- 16 Mar 2026
- Results posted
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Sleeve Jejunal Bypass VS One Anastomosis/Mini Gastric Bypass as Regards GLP-1, PYY, GIP, Insulin Resistance and Type II Diabetes Mellitus Resolution: A Prospective Partially Randomized Patient Preference Comparative Trial
- ClinicalTrials.gov ID
- NCT07475143
- Acronym / sponsor ID
- 10/2024
- Keywords
- SASJ, OAGB, GLP-1, GIP, PYY, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 16 Mar 2026 (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 aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
Detailed description
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 (as a primary outcome), PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
SASJ Group: composed of 20 patients undergoing SASJ operation. - OAGB Group: composed of 20 patients undergoing OAGB operation.
Convenience sampling was used and the sample size was 40 patients. An informed consent was taken from all patients and all data are confidential, and patients will not be mentioned by name in any published paper. Patients will have the right to refuse joining the research or withdraw at any time without affecting their chance to receive the traditional therapy at any time.
Regarding the Study Procedures, all patients will have preoperative workup including full history taking, general and local examination, laboratory profile including complete blood picture, liver function tests, kidney function tests, clotting profile, fasting and 2-hour postprandial blood glucose, HbA1C, serum insulin level, C-peptide (in non-insulin receiving patients) and Viral markers. Also Serum levels of GLP-1, PYY and GIP, thyroid profile (Free T3, T4 and TSH), pelviabdominal US, and upper GI endoscopy in patients with GERD or when an intra-gastric pathology is suspected. Cardiopulmonary assessment could be done if clinically indicated.
Operative details - One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. A transverse anastomosis is usually done.
Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigators will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus.
Regarding postoperative follow up, routine follow up visits will be arranged after one month, 3 months and 6 months. Also serum levels of GLP-1, PYY and GIP will be measured 6-8 weeks post-operative. In each visit patient will have full clinical assessment including glycemic control especially HbA1c levels, fasting blood glucose levels, post prandial serum glucose levels, serum insulin levels, C peptide levels (in non-insulin receiving patients), weight loss rate and total weight loss percentage calculated with nutritional parameters like serum calcium, iron, albumin, vitamin D and PTH will be assessed once after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Prospective Partially Randomized Patient Preference Comparative Trial
| Arm | Type | Receives |
|---|---|---|
| SASJ Group | Active comparator | Procedure: Single anastomosis sleeve jejunal bypassGroup of patients undergoing Single Anastomosis Sleeve Jejunal Bypass |
| OAGB Group | Active comparator | Procedure: One anastomosis gastric bypassGroup of patients undergoing One Anastomosis Gastric Bypass |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age from 18 to 60 years old.
- Both sexes.
- Patients with BMI ≥ 35 with Type II diabetes mellitus.
Key exclusion criteria (4 listed)
- Patients underwent previous Bariatric surgeries.
- Patients with severe systemic disease (ASA 4), such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago.
- Patients who refuse to participate in the study.
- Patients with 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 |
|---|---|---|
| Single anastomosis sleeve jejunal bypassAlso: SASJSingle anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigator will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus. | Procedure or surgery | SASJ Group |
| One anastomosis gastric bypassAlso: OAGB, MGB, Mini-gastric BypassOne anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. | Procedure or surgery | OAGB Group |
Primary outcome
Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit.
Time frame: Serum levels of GLP-1 will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.
Plasma levels of Incretin GLP-1 are measured before and after the assigned operation using ELISA kits.GLP-1 levels will be measured using (pmol/L) unit.
6 secondary outcomes
Determine the change in plasma levels GIP after the assigned operation. Serum levels will be measured using (pmol/L) unit.
Time frame: 6-8 weeks post operative
Determine the change in plasma levels Peptide-YY (PYY) after the assigned operation. Serum levels will be measured using (pmol/L) unit.
Time frame: 6-8 weeks post operative
Total weight loss percentage
Time frame: 6-8 weeks post operative
Glycemic control (Fasting)
Time frame: 6-8 weeks post operative
Glycemic control (Postprandial)
Time frame: 6-8 weeks post operative
Type II DM resolution
Time frame: 6-8 weeks post operative
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 16 Mar 2026.
- Individual participant dataSharing planned: No
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.
Mohey Eldin R ElBanna, Professor of General Surgery study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass in people with Incretin Hormones Plasma Levels and Gastric Bypass Surgery, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 4 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 16 Mar 2026. 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 Egypt. 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?
Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit. (time frame: Serum levels of GLP-1 will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative.). 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 16 Mar 2026.