Liraglutide for Low-responders After Bariatric Surgery

NCT04643301 | Withdrawn

• 1 other identifier: NOK0020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.

Conditions

Obesity; Obesity, Morbid

Keywords

Obesity; Liraglutide; GLP-1; Bariatric Surgery; Weight loss; Low-responders

Outcome Measures

Primary Outcomes (1)

• %TWL (%TWL)

  To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in low responders after bariatric surgery.

  6 months

Secondary Outcomes (5)

• Persistence

  6 months

• GI symptoms

  6 months

• %TWL

  12, 18, 24 and 36 months

• Dosage in mg

  6 months

• Eating habits

  6 months

Study Arms (1)

Adding Liraglutide to current treatment program

EXPERIMENTAL

Adding 3,0mg of Liraglutide to the current treatment program of low-responders 3 months after bariatric surgery.

Drug: Liraglutide Pen Injector

Interventions

Liraglutide Pen Injector DRUG

Daily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery.

Also known as: Saxenda

Adding Liraglutide to current treatment program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI before surgery was ≥ 35.0 kg/m2
• Patient is treated with group consultation at the NOK
• Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
• Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.

You may not qualify if:

• Type 1 or type 2 diabetes
• Decreased renal function (creatinine clearance \< 30 ml/min)
• Liver failure (all)
• Congestive heart failure or angina pectoris NYHA class III and IV
• Malignancy in history
• Pancreatitis (in history)
• Pregnancy / breast-feeding
• Inflammatory Bowel Disease
• Thyroid malignancy in history
• Use of warfarin or other coumarin derivates

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Nederlandse Obesitas Kliniek: collaborator

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• J.W. Greve, MD, PHD

  Nederlandse Obesitas Kliniek/Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study cohort will be compared to a retrospective matched cohort based on BMI before surgery, gender and type of surgery

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 25, 2020
• Study Start: December 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04