fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

NCT01583725 | Completed DMC

• 1 other identifier: 09-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery. Obese persons between the ages of 18 \& 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Weight loss; fMRI; gut peptides

Outcome Measures

Primary Outcomes (1)

• Change in brain activation in response to visual and auditory food cues

  Measures of brain brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). Over the course of 40-min fMRI scans, we will compare change in activation from 3 mo pre-surgery to 3 and 18 mo post-surgery, and predict a post-surgical decrease in activation in such regions.

  3 mo pre-surgery and 3 and 18 mo post-surgery

Secondary Outcomes (4)

• Anthropometrics and Body Composition

  3 mo pre-surgery and 3 and 18 mo post-surgery

• Mood Measures

  3 mo pre-surgery and 3 and 18 mo post-surgery

• Change in appetite-related gut peptide levels

  3 mo pre-surgery and 3 and 18 mo post-surgery

• Eating Behavior

  3 mo pre-surgery and 3 and 18 mo post-surgery

Study Arms (5)

Roux-en-Y Gastric Bypass

EXPERIMENTAL

30 subjects who plan to undergo Roux-en-Y Gastric Bypass bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.

Procedure: Liquid meal responses; Behavioral: fMRI responses to food-cues

Gastric Banding (Lap-band)

EXPERIMENTAL

30 subjects who plan to undergo Gastric Banding bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.

Procedure: Liquid meal responses; Behavioral: fMRI responses to food-cues

Formula Diet Weight Loss

EXPERIMENTAL

30 subjects who plan to begin a formula diet to lose weight. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before subjects undertake a 12-week weight loss intervention (T1), at the end of the weight loss intervention (T2) and 18 months after they completed the weight loss intervention(T3).

Procedure: Liquid meal responses; Behavioral: fMRI responses to food-cues

No Treatment

EXPERIMENTAL

30 subjects who do not undergo any treatment for weight loss. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed at baseline (T1) and at 3 months (T2) and 18 months (T3) later.

Procedure: Liquid meal responses; Behavioral: fMRI responses to food-cues

Sleeve Gastrectomy Surgery

EXPERIMENTAL

30 subjects who plan to undergo Sleeve Gastrectomy bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.

Procedure: Liquid meal responses; Behavioral: fMRI responses to food-cues

Interventions

Liquid meal responses PROCEDURE

Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.

Also known as: Meal replacement shake is the product Glytrol.

Formula Diet Weight Loss; Gastric Banding (Lap-band); No Treatment; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy Surgery

fMRI responses to food-cues BEHAVIORAL

Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.

Also known as: Food cue responses

Formula Diet Weight Loss; Gastric Banding (Lap-band); No Treatment; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI range 35-50 kg/m\^2

You may not qualify if:

• diabetes,
• smoking,
• pregnancy

Sponsors & Collaborators

• New York Obesity and Nutrition Research Center: lead
• Columbia University: collaborator
• St. Luke's-Roosevelt Hospital Center: collaborator

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Related Publications (14)

• Ongur D, Price JL. The organization of networks within the orbital and medial prefrontal cortex of rats, monkeys and humans. Cereb Cortex. 2000 Mar;10(3):206-19. doi: 10.1093/cercor/10.3.206.

  PMID: 10731217 BACKGROUND

• Le DS, Pannacciulli N, Chen K, Del Parigi A, Salbe AD, Reiman EM, Krakoff J. Less activation of the left dorsolateral prefrontal cortex in response to a meal: a feature of obesity. Am J Clin Nutr. 2006 Oct;84(4):725-31. doi: 10.1093/ajcn/84.4.725.

  PMID: 17023697 BACKGROUND

• Le DS, Pannacciulli N, Chen K, Salbe AD, Del Parigi A, Hill JO, Wing RR, Reiman EM, Krakoff J. Less activation in the left dorsolateral prefrontal cortex in the reanalysis of the response to a meal in obese than in lean women and its association with successful weight loss. Am J Clin Nutr. 2007 Sep;86(3):573-9. doi: 10.1093/ajcn/86.3.573.

  PMID: 17823419 BACKGROUND

• Rosenbaum M, Leibel RL, Hirsch J. Obesity. N Engl J Med. 1997 Aug 7;337(6):396-407. doi: 10.1056/NEJM199708073370606. No abstract available.

  PMID: 9241130 BACKGROUND

• Whitson BA, Leslie DB, Kellogg TA, Maddaus MA, Buchwald H, Billington CJ, Ikramuddin S. Entero-endocrine changes after gastric bypass in diabetic and nondiabetic patients: a preliminary study. J Surg Res. 2007 Jul;141(1):31-9. doi: 10.1016/j.jss.2007.02.022.

  PMID: 17574036 BACKGROUND

• Korner J, Bessler M, Cirilo LJ, Conwell IM, Daud A, Restuccia NL, Wardlaw SL. Effects of Roux-en-Y gastric bypass surgery on fasting and postprandial concentrations of plasma ghrelin, peptide YY, and insulin. J Clin Endocrinol Metab. 2005 Jan;90(1):359-65. doi: 10.1210/jc.2004-1076. Epub 2004 Oct 13.

  PMID: 15483088 BACKGROUND

• 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: 17968169 BACKGROUND

• Sorbara M, Geliebter A. Body image disturbance in obese outpatients before and after weight loss in relation to race, gender, binge eating, and age of onset of obesity. Int J Eat Disord. 2002 May;31(4):416-23. doi: 10.1002/eat.10046.

  PMID: 11948646 BACKGROUND

• Jirik-Babb P, Geliebter A. Comparison of psychological characteristics of binging and nonbinging obese, adult, female outpatients. Eat Weight Disord. 2003 Jun;8(2):173-7. doi: 10.1007/BF03325009.

  PMID: 12880197 BACKGROUND

• Erdmann J, Topsch R, Lippl F, Gussmann P, Schusdziarra V. Postprandial response of plasma ghrelin levels to various test meals in relation to food intake, plasma insulin, and glucose. J Clin Endocrinol Metab. 2004 Jun;89(6):3048-54. doi: 10.1210/jc.2003-031610.

  PMID: 15181097 BACKGROUND

• Marzullo P, Verti B, Savia G, Walker GE, Guzzaloni G, Tagliaferri M, Di Blasio A, Liuzzi A. The relationship between active ghrelin levels and human obesity involves alterations in resting energy expenditure. J Clin Endocrinol Metab. 2004 Feb;89(2):936-9. doi: 10.1210/jc.2003-031328.

  PMID: 14764817 BACKGROUND

• Hosoda H, Doi K, Nagaya N, Okumura H, Nakagawa E, Enomoto M, Ono F, Kangawa K. Optimum collection and storage conditions for ghrelin measurements: octanoyl modification of ghrelin is rapidly hydrolyzed to desacyl ghrelin in blood samples. Clin Chem. 2004 Jun;50(6):1077-80. doi: 10.1373/clinchem.2003.025841. No abstract available.

  PMID: 15161728 BACKGROUND

• Liu J, Prudom CE, Nass R, Pezzoli SS, Oliveri MC, Johnson ML, Veldhuis P, Gordon DA, Howard AD, Witcher DR, Geysen HM, Gaylinn BD, Thorner MO. Novel ghrelin assays provide evidence for independent regulation of ghrelin acylation and secretion in healthy young men. J Clin Endocrinol Metab. 2008 May;93(5):1980-7. doi: 10.1210/jc.2007-2235. Epub 2008 Mar 18.

  PMID: 18349056 BACKGROUND

• Geliebter A, Ladell T, Logan M, Schneider T, Sharafi M, Hirsch J. Responsivity to food stimuli in obese and lean binge eaters using functional MRI. Appetite. 2006 Jan;46(1):31-5. doi: 10.1016/j.appet.2005.09.002. Epub 2005 Dec 20.

  PMID: 16364498 BACKGROUND

Related Links

• New York Obesity Nutrition Research Center website

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Allan Geliebter, PhD

  New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: April 24, 2012
• Study Start: July 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)