A Functional Magnetic Resonance Imaging (fMRI) Study in O... | NCT00914212

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

NCT00914212

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Obesity

Interventions

Placebo
Comparator: sibutramine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Sibutramine	Drug: Comparator: sibutramine
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Single dose placebo to sibutramine in two of three treatment periods.	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs		Day 1
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs		Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C058254	sibutramine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
103
2009_597