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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Bypass Surgery; Incretin Hormones Plasma Levels
• Intervention / Treatment: Procedure: Single anastomosis sleeve jejunal bypass; Procedure: One anastomosis gastric bypass

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasiyah
    • Cairo, Abbasiyah, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients age from 18 to 60 years old.
• Both sexes.
• Patients with BMI ≥ 35 with Type II diabetes mellitus.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SASJ Group; Group of patients undergoing Single Anastomosis Sleeve Jejunal Bypass	Procedure: Single anastomosis sleeve jejunal bypass; 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.; Other Names: SASJ
Active Comparator: OAGB Group; Group of patients undergoing One Anastomosis Gastric Bypass	Procedure: One anastomosis 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.; Other Names: MGB; OAGB; Mini-gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6-8 weeks post operative
Total weight loss percentage	Measurement of total weight loss percentage (TWL%) 6-8 weeks post operative.	6-8 weeks post operative
Glycemic control (Fasting)	Full clinical assessment including fasting blood glucose levels in mg/dL	6-8 weeks post operative
Glycemic control (Postprandial)	Full clinical assessment including 2 hour post-prandial blood glucose levels in mg/dL.	6-8 weeks post operative
Type II DM resolution	Blood HbA1c levels in percentage	6-8 weeks post operative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mohey Eldin R ElBanna, Professor of General Surgery, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Diabetes Mellitus; PYY; GIP; OAGB; SASJ
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 10/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No