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

NCT07475143 | Completed

• 1 other identifier: 10/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incretin Hormones Plasma Levels; Gastric Bypass Surgery

Keywords

SASJ; OAGB; GLP-1; GIP; PYY; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Determine the change in plasma levels GIP after the assigned operation. Serum levels will be measured using (pmol/L) unit.

  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.

  6-8 weeks post operative

• Total weight loss percentage

  6-8 weeks post operative

• Glycemic control (Fasting)

  6-8 weeks post operative

• Glycemic control (Postprandial)

  6-8 weeks post operative

Study Arms (2)

SASJ Group

ACTIVE COMPARATOR

Group of patients undergoing Single Anastomosis Sleeve Jejunal Bypass

Procedure: Single anastomosis sleeve jejunal bypass

OAGB Group

ACTIVE COMPARATOR

Group of patients undergoing One Anastomosis Gastric Bypass

Procedure: One anastomosis gastric bypass

Interventions

Single anastomosis sleeve jejunal bypass PROCEDURE

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.

Also known as: SASJ

SASJ Group

One anastomosis gastric bypass PROCEDURE

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.

Also known as: OAGB, MGB, Mini-gastric Bypass

OAGB Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasiyah, 00202, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohey Eldin R ElBanna, Professor of General Surgery

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective Partially Randomized Patient Preference Comparative Trial

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: March 16, 2026
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 15, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)