Effect of Liraglutide on Weight Loss in Patients Who Have... | NCT05285397

Studies
Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.

NCT05285397

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Status

Unknown status

Last Update Posted

Mar 17, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Liraglutide Pen Injector [Saxenda]

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Mar 9, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2022

Last Update Posted Date

Mar 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Hany Ashour, Ass. Prof. of General surgery, General Committee of Teaching Hospitals and Institutes, EgyptPrincipal Investigator

Lead Sponsor

General Committee of Teaching Hospitals and Institutes, EgyptOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liraglutide	Experimental	drug starts 6 weeks post-operative until 6 months SC injection dose starting 0.6 mg/day and weekly up titrated until 3.0 mg/day	Drug: Liraglutide Pen Injector [Saxenda]
Control	No Intervention	Patients with no weight loss drug intervention after bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide Pen Injector [Saxenda]	Drug	Subcutaneous injection of GLP-1 agonist	Liraglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Total weight loss		6 months
Percentage Excess body weight loss		6 months

Secondary Outcomes

Measure	Description	Time Frame
Comorbidities		6 months
Weight		6 months
BMI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergone primary bariatric surgery
Need secondary bariatric surgery due to either weight regain (regained weight to have BMI > 35) or medical associated diseases

Exclusion Criteria:

Prior use of GLP-1 agonist
Past history of pancreatitis
Personal or family history of medullary thyroid cancer
Pregnancy or lactation
Acute coronary syndrome
Hepatic or renal dysfunction
Active malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Ashour, PhD	Contact	00201002600970		dr.mhany@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Madina Women's Hospital		Alexandria		21531	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32656729	Background	Thakur U, Bhansali A, Gupta R, Rastogi A. Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study. Obes Surg. 2021 Jan;31(1):84-92. doi: 10.1007/s11695-020-04850-4. Epub 2020 Jul 12.

Type	Date	Date Unknown
Release	May 24, 2023
Unrelease	May 29, 2023
Release	May 29, 2023
Reset	Feb 8, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 24, 2023	May 29, 2023
May 29, 2023

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones