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

Primary Purpose

Morbid Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Liraglutide Pen Injector [Saxenda]
Sponsored by
General Committee of Teaching Hospitals and Institutes, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Liraglutide, Morbid obesity, secondary bariatric surgery, revisional bariatric surgery

Eligibility Criteria

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

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

Sites / Locations

  • Madina Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Liraglutide

Control

Arm Description

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

Patients with no weight loss drug intervention after bariatric surgery

Outcomes

Primary Outcome Measures

Percentage Total weight loss
Percentage Excess body weight loss

Secondary Outcome Measures

Comorbidities
Weight
BMI
HbA1C
Fasting Blood Glucose (FBG)
HOMA-IR
Resolution of type 2 Diabetes Mellitus
Blood pressure
Lipid profile
Sleep apnea

Full Information

First Posted
March 9, 2022
Last Updated
March 9, 2022
Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05285397
Brief Title
Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.
Official Title
Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 10, 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Liraglutide, Morbid obesity, secondary bariatric surgery, revisional bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients with no weight loss drug intervention after bariatric surgery
Intervention Type
Drug
Intervention Name(s)
Liraglutide Pen Injector [Saxenda]
Intervention Description
Subcutaneous injection of GLP-1 agonist
Primary Outcome Measure Information:
Title
Percentage Total weight loss
Time Frame
6 months
Title
Percentage Excess body weight loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comorbidities
Time Frame
6 months
Title
Weight
Time Frame
6 months
Title
BMI
Time Frame
6 months
Title
HbA1C
Time Frame
6 months
Title
Fasting Blood Glucose (FBG)
Time Frame
6 months
Title
HOMA-IR
Time Frame
6 months
Title
Resolution of type 2 Diabetes Mellitus
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Lipid profile
Time Frame
6 months
Title
Sleep apnea
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ashour, PhD
Phone
00201002600970
Email
dr.mhany@gmail.com
Facility Information:
Facility Name
Madina Women's Hospital
City
Alexandria
ZIP/Postal Code
21531
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ashour, PhD
Phone
00201002600970
Email
dr.mhany@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32656729
Citation
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.
Results Reference
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Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.

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