NCT04414072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

May 28, 2020

Last Update Submit

May 30, 2020

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • hormonal change

    GIT hormones (Ghrelin, secretin, PYY, GLP-1)

    one year

Study Arms (3)

laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR
Procedure: sleeve gastrectomy with loop bipartition

mini gastric bypass

ACTIVE COMPARATOR
Procedure: sleeve gastrectomy with loop bipartition

sleeve gastrectomy with loop bipartition

ACTIVE COMPARATOR
Procedure: sleeve gastrectomy with loop bipartition

Interventions

sleeve gastrectomy with loop bipartitionPROCEDURE

operations to decrease weight

Also known as: minigastric bypass
laparoscopic sleeve gastrectomymini gastric bypasssleeve gastrectomy with loop bipartition

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All morbid obese patients

You may not qualify if:

  • GIT diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: surgeries
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 4, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG(1)