ObesityPhase 3NCT01015976

A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects

A Phase 3 study testing bariatric surgery in people with Obesity, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: bariatric surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects between the ages of 18 and 60 years.
Subjects must be of good general health by history and physical exam.
Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.
Five subjects matched for body mass index, age and sex to the post bariatric surgery group.
No contraindications to receiving a single dose of 100 mg of sertraline.
Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline.

Who cannot join

Allergy to sertraline or any of its constituents.
Candidates currently receiving sertraline or any other antidepressant.
Candidates currently receiving a medication that interacts with sertraline (Zoloft)
Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.
Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.

Show all 9Show fewer

Candidates who have participated in an investigational drug study in past 30 days.
Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
Candidates who are pregnant or nursing at time of study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Neuropsychiatric Research Institute
Fargo, North Dakota, 58103

Other trials in United States

About this study

Read the detailed description

Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.

Conditions: Obesity
Being tested: bariatric surgery, control
Keywords: Gastric Bypass, Sertraline, Pharmacokinetics
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bariatric surgeryProcedure or surgery
Roux en Y bariatric surgery
controlOther
No surgery

Study groups in NCT01015976
Study group	Role	What they receive
Post bariatric surgery	Experimental	Roux en Y bariatric surgery Receives: Procedure: bariatric surgery
Control	Other	No surgery Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC Post Surgery (n =5) Compared to AUC Control (n=5)
AUC of surgery group compared to the AUC of control group
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Apr 2010

First posted18 Nov 2009 (estimated)
Study startFeb 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies 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 3
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015976
Sponsor's protocol ID: 200803-272
Status last verified: Feb 2014
First submitted: 1 Oct 2009
Last updated: 31 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
ClinicalTrials.gov ID: NCT01015976
Acronym / sponsor ID: 200803-272
Conditions: Obesity
Keywords: Gastric Bypass, Sertraline, Pharmacokinetics
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
Collaborators: University of North Dakota
Study start: Feb 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 31 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Post bariatric surgery	Experimental	Procedure: bariatric surgeryRoux en Y bariatric surgery
Control	Other	Other: controlNo surgery

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male or female subjects between the ages of 18 and 60 years.
Subjects must be of good general health by history and physical exam.
Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.
Five subjects matched for body mass index, age and sex to the post bariatric surgery group.
No contraindications to receiving a single dose of 100 mg of sertraline.

Key exclusion criteria (9 listed)

Allergy to sertraline or any of its constituents.
Candidates currently receiving sertraline or any other antidepressant.
Candidates currently receiving a medication that interacts with sertraline (Zoloft)
Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.
Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.

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
bariatric surgeryRoux en Y bariatric surgery	Procedure or surgery	Post bariatric surgery
controlNo surgery	Other	Control

Primary outcome

AUC Post Surgery (n =5) Compared to AUC Control (n=5)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours
AUC of surgery group compared to the AUC of control group

Results and safety

Results posted to the registry on 31 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	5	5
Control Group	5	5

Primary outcome: AUC Post Surgery (n =5) Compared to AUC Control (n=5)

Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours. Mean (Standard Deviation). Unit: ng-hr/mL

Measure	Control n = 10
Post surgery	124.4 (55.5)
Control	314.8 (129.6)

Population analysed: Per protocol

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Drug	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): small sample size absence of men in either group. short data collection period, characterization of the linear elimination phase of the AUC was not possible.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

James Roerig, PharmD, BCPP principal investigator

Neuropsychiatric Research Institute and University of North Dakota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bariatric surgery in people with Obesity, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.

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 6 inclusion and 9 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 31 Mar 2014. 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 United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC Post Surgery (n =5) Compared to AUC Control (n=5) (time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015976.

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 31 Mar 2014.