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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
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 28, 2020
Last Updated
May 30, 2020
Sponsor
Minia University
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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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