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

Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05285397
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.7
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liraglutide Pen Injector [Saxenda]
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
Anticipated Study Start Date :
Mar 10, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percentage Total weight loss [6 months]

  2. Percentage Excess body weight loss [6 months]

Secondary Outcome Measures

  1. Comorbidities [6 months]

  2. Weight [6 months]

  3. BMI [6 months]

  4. HbA1C [6 months]

  5. Fasting Blood Glucose (FBG) [6 months]

  6. HOMA-IR [6 months]

  7. Resolution of type 2 Diabetes Mellitus [6 months]

  8. Blood pressure [6 months]

  9. Lipid profile [6 months]

  10. Sleep apnea [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Madina Women's Hospital Alexandria Egypt 21531

Sponsors and Collaborators

  • General Committee of Teaching Hospitals and Institutes, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Hany Ashour, Ass. Prof. of General surgery, General Committee of Teaching Hospitals and Institutes, Egypt
ClinicalTrials.gov Identifier:
NCT05285397
Other Study ID Numbers:
  • Liraglutide1
First Posted:
Mar 17, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Mohamed Hany Ashour, Ass. Prof. of General surgery, General Committee of Teaching Hospitals and Institutes, Egypt
Liraglutide
Morbid obesity
secondary bariatric surgery
revisional bariatric surgery
Additional relevant MeSH terms:
Obesity, Morbid
Weight Loss
Liraglutide

Study Results

No Results Posted as of Mar 17, 2022