ObesityNEWSNCT01228097
Neural Response to Eating and Weight Status
An observational study of Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will compare brain and hormone responses to food images (and food) in women who undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss surgery, with the intent of remaining relatively weight… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jan 2015
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with extreme obesity (i.e., BMI 40 kg/m2) or moderate obesity (BMI 35.0-39.9 kg/m2) plus significant weight-related comorbidities.
Who may be able to join
- Women
- Over 18 years old
- BMI of 40 kg/ m2 (or 35 kg/m2 in the presence of significant weight-related comorbidities, including established coronary artery disease, established peripheral arterial disease, symptomatic carotid artery disease, sleep apnea, metabolic syndrome, cardiomyopathy, hypertension, and debilitating joint pain).
- Non-surgical group must be willing to remain weight stable and not seek weight loss (i.e., defined as remaining within 5% of baseline weight).
Who cannot join
- Weight > 350 pounds the maximum weight that can be accommodated in the scanner); supine abdominal width (with arms folded above) > 60 cm or sagittal diameter > 50 cm (i.e., these are the maximum dimensions that can be accommodated in the scanner)
- Pregnancy or lactation
- Type 1 or type 2 diabetes
- Severe major depression or other psychiatric disorder that significantly interferes with daily living
- Substance use disorder (current or in remission 1 year)
- Current use of nicotine or any illicit drug
Show all 12Show fewer
- Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- Use of weight loss medications or other agents known to affect body weight or blood glucose (e.g., glucocorticoids, second-generation antipsychotic medications)
- Lack of capacity to provide informed consent
- Non-surgical participants interested in losing weight in the next 2 years
- Plans to relocate from the area within 2 years
- Principal Investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Changes in Neural Response to Eating After Bariatric Surgery: MRI Results
This study will compare brain and hormone responses to food images (and food) in women who undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your present weight). The investigators will use magnetic resonance imaging (MRI) to see how the brain responds to pictures of food and to consuming a liquid meal replacement. The investigators wish to determine whether the two surgeries have different effects on appetite, as observable in the brain, and whether the possible effects on appetite differ from those in participants who have a similar body weight but remain relatively weight stable. The investigators also will draw blood to determine how "hunger" and "fullness" hormones change after eating and to see if there are any differences among the three groups. The study is being sponsored by the National Institutes of Health (NIH).
Read the detailed description
We hypothesize that RYGB-treated patients will exhibit greater reductions (from baseline) in BOLD response in areas associated with homeostatic and hedonic eating than will both LAGB/LSG and control patients. We also expect that LAGB/LSG patients (as a result of hormonal changes occurring with weight loss) will display greater increases in BOLD response to images of highly palatable foods than will extremely obese controls.
We expect that RYGB-treated patients will show larger increases (relative to baseline) in postprandial GLP-1 and PYY3-36 than the LAGB/LSG and obese control groups. We will also compare changes in ghrelin in the three groups. We predict that patients who undergo RYGB will have greater reductions in ghrelin than will control subjects.
We expect that RYGB-treated patients will demonstrate greater postprandial changes (relative to baseline) in brain activity in the homeostatic and hedonic feeding areas (suggesting normalization of satiety and of neural processing of food reward) than will patients who undergo LAGB/LSG or who do not seek weight loss.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass | Participants who receive gastric bypass surgery. | |
| Principally Restrictive Surgery | Participants who receive gastric banding or sleeve gastrectomy surgery. | |
| Weight Stable | Participants who remain weight stable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare changes in BOLD response to images of high-calorie foods in RYGB patients, LAGB/LSG patients, and untreated controls.
Measured: Baseline, 6-Months, 18-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas A. Wadden, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228097
- Sponsor's protocol ID
- R01DK085615
- Acronym
- NEWS
- Status last verified
- Dec 2011
- First submitted
- 22 Oct 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarkar S, Anokye-Danso F, Tronieri JS, Millar JS, Alamuddin N, Wadden TA, Ahima RS. Differential Effects of Roux-en-Y Gastric Bypass Surgery and Laparoscopic Sleeve Gastrectomy on Fatty Acid Levels. Obes Surg. 2019 Dec;29(12):3941-3947. doi: 10.1007/s11695-019-04062-5.
PubMed 31290107Alamuddin N, Vetter ML, Ahima RS, Hesson L, Ritter S, Minnick A, Faulconbridge LF, Allison KC, Sarwer DB, Chittams J, Williams NN, Hayes MR, Loughead JW, Gur R, Wadden TA. Changes in Fasting and Prandial Gut and Adiposity Hormones Following Vertical Sleeve Gastrectomy or Roux-en-Y-Gastric Bypass: an 18-Month Prospective Study. Obes Surg. 2017 Jun;27(6):1563-1572. doi: 10.1007/s11695-016-2505-5.
PubMed 28004304
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Neural Response to Eating After Bariatric Surgery: MRI Results
- ClinicalTrials.gov ID
- NCT01228097
- Acronym / sponsor ID
- NEWS / R01DK085615
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Oct 2010 (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 compare brain and hormone responses to food images (and food) in women who undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your present weight). The investigators will use magnetic resonance imaging (MRI) to see how the brain responds to pictures of food and to consuming a liquid meal replacement. The investigators wish to determine whether the two surgeries have different effects on appetite, as observable in the brain, and whether the possible effects on appetite differ from those in participants who have a similar body weight but remain relatively weight stable. The investigators also will draw blood to determine how "hunger" and "fullness" hormones change after eating and to see if there are any differences among the three groups. The study is being sponsored by the National Institutes of Health (NIH).
Detailed description
We hypothesize that RYGB-treated patients will exhibit greater reductions (from baseline) in BOLD response in areas associated with homeostatic and hedonic eating than will both LAGB/LSG and control patients. We also expect that LAGB/LSG patients (as a result of hormonal changes occurring with weight loss) will display greater increases in BOLD response to images of highly palatable foods than will extremely obese controls.
We expect that RYGB-treated patients will show larger increases (relative to baseline) in postprandial GLP-1 and PYY3-36 than the LAGB/LSG and obese control groups. We will also compare changes in ghrelin in the three groups. We predict that patients who undergo RYGB will have greater reductions in ghrelin than will control subjects.
We expect that RYGB-treated patients will demonstrate greater postprandial changes (relative to baseline) in brain activity in the homeostatic and hedonic feeding areas (suggesting normalization of satiety and of neural processing of food reward) than will patients who undergo LAGB/LSG or who do not seek weight loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass | – | –Participants who receive gastric bypass surgery. |
| Principally Restrictive Surgery | – | –Participants who receive gastric banding or sleeve gastrectomy surgery. |
| Weight Stable | – | –Participants who remain weight stable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with extreme obesity (i.e., BMI 40 kg/m2) or moderate obesity (BMI 35.0-39.9 kg/m2) plus significant weight-related comorbidities.
Key inclusion criteria (4 listed)
- Women
- Over 18 years old
- BMI of 40 kg/ m2 (or 35 kg/m2 in the presence of significant weight-related comorbidities, including established coronary artery disease, established peripheral arterial disease, symptomatic carotid artery disease, sleep apnea, metabolic syndrome, cardiomyopathy, hypertension, and debilitating joint pain).
- Non-surgical group must be willing to remain weight stable and not seek weight loss (i.e., defined as remaining within 5% of baseline weight).
Key exclusion criteria (12 listed)
- Weight > 350 pounds the maximum weight that can be accommodated in the scanner); supine abdominal width (with arms folded above) > 60 cm or sagittal diameter > 50 cm (i.e., these are the maximum dimensions that can be accommodated in the scanner)
- Pregnancy or lactation
- Type 1 or type 2 diabetes
- Severe major depression or other psychiatric disorder that significantly interferes with daily living
- Substance use disorder (current or in remission 1 year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare changes in BOLD response to images of high-calorie foods in RYGB patients, LAGB/LSG patients, and untreated controls.
Time frame: Baseline, 6-Months, 18-Months
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 10 Mar 2015.
- Derived from this study: PubMed 31290107Sarkar S, Anokye-Danso F, Tronieri JS, Millar JS, Alamuddin N, Wadden TA, Ahima RS. Differential Effects of Roux-en-Y Gastric Bypass Surgery and Laparoscopic Sleeve Gastrectomy on Fatty Acid Levels. Obes Surg. 2019 Dec;29(12):3941-3947. doi: 10.1007/s11695-019-04062-5.
- Derived from this study: PubMed 28004304Alamuddin N, Vetter ML, Ahima RS, Hesson L, Ritter S, Minnick A, Faulconbridge LF, Allison KC, Sarwer DB, Chittams J, Williams NN, Hayes MR, Loughead JW, Gur R, Wadden TA. Changes in Fasting and Prandial Gut and Adiposity Hormones Following Vertical Sleeve Gastrectomy or Roux-en-Y-Gastric Bypass: an 18-Month Prospective Study. Obes Surg. 2017 Jun;27(6):1563-1572. doi: 10.1007/s11695-016-2505-5.
- Related InfoLink provided by the sponsor.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Thomas A. Wadden, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Pennsylvania 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 4 inclusion and 12 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 10 Mar 2015. 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.
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?
To compare changes in BOLD response to images of high-calorie foods in RYGB patients, LAGB/LSG patients, and untreated controls. (time frame: Baseline, 6-Months, 18-Months). 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 NCT01228097, which also lists 2 linked publications.
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 10 Mar 2015.