ObesityPhase 1NCT00914212

A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)

A Phase 1 study testing Comparator: sibutramine in people with Obesity, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Comparator: sibutramine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: No sites listed yet
Study dates: May 2009to Aug 2009
Phase: Phase 1
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subject is a male between 18 and 45 years of age
Subject has a body mass index (BMI) between 28 and 35 kg/m^2
Subject does not weigh more than 140 kg (309 lbs) at the screening visit
Subject is right-handed
Subject is a non-smoker
Subject is in generally good health
Subject has normal or corrected to normal vision

Who cannot join

Subject works a night shift within 3 days of each treatment visit
Subject has permanent cosmetic or metallic objects in his body
Subject has attention deficit hyperactivity disorder (ADHD)
Subject has or had sleep apnea
Subject has a history of neurological disorders
Subject has a history of any clinically significant disease or condition

Show all 9Show fewer

Subject is vegan or vegetarian
Subject has a history of eating disorders
Subject has had previous bariatric surgery

About this study

Official title: A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men

This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.

Conditions: Obesity
Being tested: Placebo, Comparator: sibutramine
Medical subject headings: Obesity

What participants receive

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

PlaceboDrug
Single dose placebo to sibutramine in two of three treatment periods.
Comparator: sibutramineDrug
Also called sibutramine
Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.

Study groups in NCT00914212
Study group	Role	What they receive
1	Active comparator	Sibutramine Receives: Drug: Comparator: sibutramine
2	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
Measured: Day 1

Secondary outcomes (7)

Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
Measured: Day 1
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
Measured: Day 1
AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
Measured: Day 1
Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
Measured: Day 1
rCBF during the fed condition with placebo or sibutramine in the six ROIs
Measured: Day 1
Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs
Measured: Day 1
Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo
Measured: Day 1

Timeline

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

May 2009Aug 2009

First posted4 Jun 2009 (estimated)
Study startMay 2009
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 1
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00914212
Sponsor's protocol ID: 0000-103
Other IDs: 103, 2009_597
Status last verified: Oct 2015
First submitted: 1 Jun 2009
Last updated: 12 Oct 2015
Results posted: No
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?

Official record

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Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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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
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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men
ClinicalTrials.gov ID: NCT00914212
Acronym / sponsor ID: 0000-103
Conditions: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 4 Jun 2009 (estimated)
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.

This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Comparator: sibutramineSibutramine
2	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Subject is a male between 18 and 45 years of age
Subject has a body mass index (BMI) between 28 and 35 kg/m^2
Subject does not weigh more than 140 kg (309 lbs) at the screening visit
Subject is right-handed
Subject is a non-smoker

Key exclusion criteria (9 listed)

Subject works a night shift within 3 days of each treatment visit
Subject has permanent cosmetic or metallic objects in his body
Subject has attention deficit hyperactivity disorder (ADHD)
Subject has or had sleep apnea
Subject has a history of neurological disorders

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
PlaceboSingle dose placebo to sibutramine in two of three treatment periods.	Drug	2
Comparator: sibutramineAlso: sibutramineSingle dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.	Drug	1

Primary outcome

Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
Time frame: Day 1

7 secondary outcomes

Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
Time frame: Day 1
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
Time frame: Day 1
AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
Time frame: Day 1
Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
Time frame: Day 1
rCBF during the fed condition with placebo or sibutramine in the six ROIs
Time frame: Day 1
Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs
Time frame: Day 1
Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo
Time frame: Day 1

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 12 Oct 2015.

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Comparator: sibutramine in people with Obesity, run by Merck Sharp & Dohme LLC.

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 7 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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?

Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI) (time frame: Day 1). 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 NCT00914212.

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 12 Oct 2015.