NCT01140711

Brief Summary

Aim of study: To evaluate changes in feeding-related neural activity after different bariatric procedures in morbidly obese patients. Relationship of gut hormone levels will be assessed as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 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

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

4.3 years

First QC Date

June 8, 2010

Last Update Submit

February 4, 2018

Conditions

Morbid ObesitySatiety

Outcome Measures

Primary Outcomes (1)

  • Change in neuronal activity response to visual food stimuli after bariatric surgery

    Baseline and 6 months

Secondary Outcomes (2)

  • Change in circulating blood incretin levels after bariatric surgery

    Baseline and 6 months

  • Difference in measured parameters between sleeve gastrectomy and gastric bypass

    Baseline and 6 months

Study Arms (2)

Gastric bypass

EXPERIMENTAL

Patients submitted to gastric bypass for treatment of morbid obesity

Procedure: fMRI imaging following visual stimulation of food and non-food images

Sleeve gastrectomy

EXPERIMENTAL

Patients submitted to sleeve gastrectomy for treatment of morbid obesity

Procedure: fMRI imaging following visual stimulation of food and non-food images

Interventions

fMRI imaging following visual stimulation of food and non-food imagesPROCEDURE

fMRI Scans will be performed in a 3 tesla MRI scanner. All subjects will be scanned for anatomical imaging without injection of contrast material. These structural images will be used to localize the functional data obtained. Functional test will include several measurements of brain activity while viewing visual stimuli. fMRI allows collection of information about brain activity with good spatial and temporal resolution. Protocols allow rapid assessment of regional activation in different brain regions during exposure to different visual stimuli.It provides a detailed functional map. Scan test protocol includes anatomical measurement - 3D FSPGE T1w sequence, Asset DTI and repeated fMRI measurements (based on echo EPI, T2 \* w, BOLD sequences). Test paradigms include picture collections of various foods non-food objects similar in size, color and shape.

Gastric bypassSleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Morbidly obese
  • Having passed standard preoperative, multidisciplinary evaluation and deemed acceptable for surgery

You may not qualify if:

  • Claustrophobic
  • Having other cotnraindication for MRI testing (metalic implants, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (4)

  • Fuhrer D, Zysset S, Stumvoll M. Brain activity in hunger and satiety: an exploratory visually stimulated FMRI study. Obesity (Silver Spring). 2008 May;16(5):945-50. doi: 10.1038/oby.2008.33. Epub 2008 Feb 21.

    PMID: 18292747BACKGROUND

  • Stice E, Spoor S, Bohon C, Veldhuizen MG, Small DM. Relation of reward from food intake and anticipated food intake to obesity: a functional magnetic resonance imaging study. J Abnorm Psychol. 2008 Nov;117(4):924-35. doi: 10.1037/a0013600.

    PMID: 19025237BACKGROUND

  • Cummings DE, Weigle DS, Frayo RS, Breen PA, Ma MK, Dellinger EP, Purnell JQ. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery. N Engl J Med. 2002 May 23;346(21):1623-30. doi: 10.1056/NEJMoa012908.

    PMID: 12023994BACKGROUND

  • le Roux CW, Welbourn R, Werling M, Osborne A, Kokkinos A, Laurenius A, Lonroth H, Fandriks L, Ghatei MA, Bloom SR, Olbers T. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg. 2007 Nov;246(5):780-5. doi: 10.1097/SLA.0b013e3180caa3e3.

    PMID: 17968169BACKGROUND

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
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2015

Study Completion

February 1, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

IL(1)