Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial
Weight Loss and Change in Ghrelin and GLP-1 Levels After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: a Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedOctober 22, 2019
October 1, 2019
2.8 years
October 18, 2019
October 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
excess weight loss
the percentage of excess weight loss after surgery
12 months after surgery
Study Arms (2)
Sleeve gastrectomy
ACTIVE COMPARATOR5-port standard sleeve gastrectomy was conducted
one anastomosis gastric bypass
ACTIVE COMPARATOR5-port standard one-anastomosis gastric bypass was performed
Interventions
5-port one anastomosis gastric bypass
Eligibility Criteria
You may qualify if:
- Adult patients of both genders with morbid obesity (defined as BMI \> 40 kg/m2 or \> 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.
You may not qualify if:
- patients ageing more than 60 years
- patients with endocrine disorders
- patients with psychiatric disorders that influence perception of the study protocol
- patients unfit for general anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of surgery
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 22, 2019
Study Start
March 1, 2016
Primary Completion
December 1, 2018
Study Completion
November 1, 2019
Last Updated
October 22, 2019
Record last verified: 2019-10