NCT03563287

Brief Summary

Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required. The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs. The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4). The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

June 8, 2018

Last Update Submit

June 19, 2018

Conditions

Obesity, MorbidBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

  • Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB

    baseline, 1 hour, 2 hour, 4 hour and 6 hour

  • Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB

    baseline, 1 hour, 2 hour, 4 hour and 6 hour

Secondary Outcomes (2)

  • Metabolic ratios of parent compounds and corresponding metabolites before LRYGB

    baseline, 1 hour, 2 hour, 4 hour and 6 hour

  • Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB

    baseline, 1 hour, 2 hour, 4 hour and 6 hour

Study Arms (2)

Phenotyping cocktail of 9 CYP probe drugs before surgery

EXPERIMENTAL
Drug: cocktail of nine CYP probe drugs

Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery

EXPERIMENTAL
Drug: cocktail of nine CYP probe drugs

Interventions

cocktail of nine CYP probe drugsDRUG

Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules.

Phenotyping cocktail of 9 CYP probe drugs 1 year after surgeryPhenotyping cocktail of 9 CYP probe drugs before surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 40 kg/m2 or BMI 35-40 kg/m2 and a comorbidity or its risk factor, such as type 2 diabetes, hypertension, sleep apnea, osteoarthritis of weight bearing joints or polycystic ovarian syndrome;
  • previous conservative treatment for obesity had been proven to be ineffective;
  • patients were assigned to undergo LRYGB surgery
  • patients are able to give a written inform consent.

You may not qualify if:

  • smokers
  • consuming alcohol more than 20 g per day were included in the study
  • taking drugs which alter CYPs activity
  • history of hypersensitivity to the drugs used in the cocktail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, Finland

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

January 27, 2012

Primary Completion

December 10, 2014

Study Completion

December 10, 2014

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)