Obesity, MorbidNCT03563287
Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs
A study testing cocktail of nine CYP probe drugs in people with Obesity, Morbid and Bariatric Surgery Candidate, run by University of Eastern Finland at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- cocktail of nine CYP probe drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFinland
- Study dates
- 27 Jan 2012to 10 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
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.
Read more
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.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- cocktail of nine CYP probe drugs
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Phenotyping cocktail of 9 CYP probe drugs before surgery | Experimental | Not described Receives: Drug: cocktail of nine CYP probe drugs |
| Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery | Experimental | Not described Receives: Drug: cocktail of nine CYP probe drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB
Measured: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB
Measured: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Secondary outcomes (2)
Metabolic ratios of parent compounds and corresponding metabolites before LRYGB
Measured: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB
Measured: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start27 Jan 2012
- Primary completion10 Dec 2014
- Study completion10 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Research Foundation, Finland, Finnish Cultural Foundation, Kuopio University Hospital, Academy of Finland
- Responsible party
- Principal investigator, Jussi Pihlajamäki, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563287
- Sponsor's protocol ID
- NUDROBE
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
- ClinicalTrials.gov ID
- NCT03563287
- Acronym / sponsor ID
- NUDROBE
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Diabetes Research Foundation, Finland, Finnish Cultural Foundation, Kuopio University Hospital, Academy of Finland
- Study start
- 27 Jan 2012 (actual)
- Primary completion
- 10 Dec 2014 (actual)
- Study completion
- 10 Dec 2014 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cocktail of nine CYP probe drugsTwo 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. | Drug | Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery, Phenotyping cocktail of 9 CYP probe drugs before surgery |
Primary outcome
Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB
Time frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB
Time frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
2 secondary outcomes
Metabolic ratios of parent compounds and corresponding metabolites before LRYGB
Time frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB
Time frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cocktail of nine CYP probe drugs in people with Obesity, Morbid and Bariatric Surgery Candidate, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB (time frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.