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NCT05285397 Clinical Trial

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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05285397
Other study ID # Liraglutide1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date September 2022

Study information
Verified date March 2022
Source General Committee of Teaching Hospitals and Institutes, Egypt
Contact Mohamed Ashour, PhD
Phone 00201002600970
Email dr.mhany@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liraglutide Pen Injector [Saxenda]
Subcutaneous injection of GLP-1 agonist

Locations
Country Name City State
Egypt Madina Women's Hospital Alexandria

Sponsors (1)
Lead Sponsor Collaborator
General Committee of Teaching Hospitals and Institutes, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage Total weight loss 6 months
Primary Percentage Excess body weight loss 6 months
Secondary Comorbidities 6 months
Secondary Weight 6 months
Secondary BMI 6 months
Secondary HbA1C 6 months
Secondary Fasting Blood Glucose (FBG) 6 months
Secondary HOMA-IR 6 months
Secondary Resolution of type 2 Diabetes Mellitus 6 months
Secondary Blood pressure 6 months
Secondary Lipid profile 6 months
Secondary Sleep apnea 6 months
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