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

March 9, 2022 updated by: Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt

Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21531
        • Madina Women's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
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]
Subcutaneous injection of GLP-1 agonist
No Intervention: Control
Patients with no weight loss drug intervention after bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Total weight loss
Time Frame: 6 months
6 months
Percentage Excess body weight loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 6 months
6 months
Blood pressure
Time Frame: 6 months
6 months
BMI
Time Frame: 6 months
6 months
Lipid profile
Time Frame: 6 months
6 months
HbA1C
Time Frame: 6 months
6 months
Comorbidities
Time Frame: 6 months
6 months
Fasting Blood Glucose (FBG)
Time Frame: 6 months
6 months
HOMA-IR
Time Frame: 6 months
6 months
Resolution of type 2 Diabetes Mellitus
Time Frame: 6 months
6 months
Sleep apnea
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 10, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liraglutide1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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