Local GIT Hormones After Bariatric Maneuvers
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sleeve gastrectomy with loop bipartition
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
All morbid obese patients
-
Exclusion Criteria:
GIT diseases
Sites / Locations
- Minia universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
laparoscopic sleeve gastrectomy
mini gastric bypass
sleeve gastrectomy with loop bipartition
Arm Description
Outcomes
Primary Outcome Measures
hormonal change
GIT hormones (Ghrelin, secretin, PYY, GLP-1)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04414072
Brief Title
Local GIT Hormones After Bariatric Maneuvers
Official Title
Effect of Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides.
Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients.
Detailed Description
Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients. Age ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist, Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done after two weeks and after 2 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
surgeries
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Title
mini gastric bypass
Arm Type
Active Comparator
Arm Title
sleeve gastrectomy with loop bipartition
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy with loop bipartition
Other Intervention Name(s)
minigastric bypass
Intervention Description
operations to decrease weight
Primary Outcome Measure Information:
Title
hormonal change
Description
GIT hormones (Ghrelin, secretin, PYY, GLP-1)
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All morbid obese patients
-
Exclusion Criteria:
GIT diseases
Facility Information:
Facility Name
Minia university
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minia University
Phone
(086) 2366149
Email
minia.edu.org@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Local GIT Hormones After Bariatric Maneuvers
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