Clinical Trials Logo
  1. Home
  2. Obesity, Morbid
  3. NCT03476525
  4. Details
NCT03476525 Clinical Trial

Bariatric Surgery and Pharmacokinetics of Fluoxetine

Obesity, Morbid Clinical Trial

Official title:
Bariatric Surgery and Pharmacokinetics Fluoxetine: BAR-MEDS Fluoxetine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03476525
Other study ID # 2016/1145L
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2016
Est. completion date October 2026

Study information
Verified date April 2023
Source Norwegian University of Science and Technology
Contact Magnus Strømmen, MSc
Phone 0047 72829970
Email magnus.strommen@stolav.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on fluoxetine are investigated.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway - Being a Norwegian citizen Exclusion Criteria: - Having previously undergone resections in the GI-tract

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluoxetine
Patients are tested for their normal prescription fluoxetine medication

Locations
Country Name City State
Norway St. Olavs University Hospital Trondheim

Sponsors (5)
Lead Sponsor Collaborator
Norwegian University of Science and Technology Alesund Hospital, Namsos Hospital, St. Olavs Hospital, Volvat Medisinsk Senter Stokkan

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fluoxetine concentration in blood serum (area under curve (AUC)) From baseline to 1 year postoperatively
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT01550601 - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity N/A
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting NCT04209842 - Effectiveness Gastric Balloon in Obese Adolescents N/A
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02590406 - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation N/A
Completed NCT01840020 - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed NCT01183975 - Swedish Adjustable Gastric Banding Observational Cohort Study N/A
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Terminated NCT05993169 - Body Composition Optimization Intervention RCT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Recruiting NCT05554016 - The UFO (Ultra Processed Foods in Obesity) Project
Completed NCT05519423 - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals N/A
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study