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Mechanisms Underlying Predictors of Success From Obesity Surgery

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ClinicalTrials.gov Identifier: NCT02697253
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ari Shechter, Columbia University

Brief Summary:

The goal of this project is to identify predictors of success in the treatment of obesity after roux-en-y bariatric surgery. The specific aims of this proposal are to:

  1. employ behavioral tests of mechanisms that control food intake in normal weight individuals, to determine which intake control mechanisms lead to changes after Roux-en-y gastric bypass (RYGBP); and
  2. measure behavioral and psycho-social predictors of weight loss and food intake reduction, so as to determine which are most predictive of successful weight loss and food intake reduction.

The mechanism investigators propose to account for success is reduction in food intake brought about by the pattern of hormone release, particularly glucagon-like peptide-1 (GLP-1), and gastric distention, both known to underlie satiation, coupled with post-ingestive changes in reinforcing value of food and motivation to consume. Tests of the hypothesis will be done by measuring responses to tasting, working for, and consuming, foods on sensory, motivational, cognitive, and physiological variables, including amount consumed and rate of eating under standardized conditions, before surgery and at a two year follow up visit. In addition the inhibitor exendin-9-39 (EX9) will be infused before a meal to determine whether blockade of GLP-1 Receptor after surgery partially reverses intake reduction. Investigators predict that successful patients will show changes that favor reduction in food intake, rate of eating, motivation to consume, reward value of foods, and a hormone profile that has been shown to generate satiation and maintain reduction in intake (e.g. increased Cholecystokinin (CCK), GLP-1, reduced ghrelin). To the extent that psycho-social and cognitive factors may override physiological brakes to eating behavior, the subjects may fail to achieve success, and consequently the failure may be predicted from over-impulsiveness or inability to suppress working for rewarding food stimuli. To test these hypotheses, a total of 50 patients will be enrolled prior to RYGBP and restudied 2 years after the surgery. Based on known high attrition in this population and our past 10 year experience with bariatric research, it is estimated that 100 patients will need to be enrolled over 2 years to obtain 50 who complete testing at 2 years. EX9 studies will be done in a subset of 30 completers, only after roux-en-y gastric bypass (RYGBP), 15 failure (<15% weight loss) 15 success ( >30% weight loss).


Condition or disease Intervention/treatment Phase
Obesity Drug: Exendin 9-39 Drug: Placebo Not Applicable

Detailed Description:
Obesity is a major public health as well as economic (expense of treating) problem world-wide, and Roux-en-Y gastric bypass (RYGB) and Sleeve Gastrectomy (SG) surgeries are effective treatments. A barrier to progress is that between 25% and 40% patients were not successful in achieving and maintaining at least 30% weight loss, which is considered medically successful for this operation. Understanding the mechanisms that contribute to success or failure of this operation is an unsolved problem in obesity research which this proposal is addressing. The focus of this project is to identify mechanisms that contribute to suppression of food intake following bariatric surgery, and to investigate whether these mechanisms predict long term success following bariatric surgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms Underlying Predictors of Success From Obesity Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Successful drug
Participants who lost more than 30% body weight at 2 years post-roux-en-y bypass surgery will receive infusion of Exendin 9-39 prior to an intake test.
Drug: Exendin 9-39
Infusion of exendin 9-39 at the rate of 600 pmol/kg/min, infusion time 60 minutes. An average of 12.1 ml will be infused in a forearm vein during an oral glucose (50 g) preload.

Experimental: Unsuccessful drug
Participants who lost less than 15% body weight at 2 years post-roux-en-y bypass surgery will receive infusion of Exendin 9-39 prior to an intake test.
Drug: Exendin 9-39
Infusion of exendin 9-39 at the rate of 600 pmol/kg/min, infusion time 60 minutes. An average of 12.1 ml will be infused in a forearm vein during an oral glucose (50 g) preload.

Placebo Comparator: Success placebo
Participants who lost more than 30% body weight at 2 years post-roux-en-y bypass surgery will receive placebo infusion prior to an intake test.
Drug: Placebo
Infusion of 0.9% saline solution (placebo infusion) for 60 minutes. An average of 12.1 ml will be infused in a forearm vein during an oral glucose (50 g) preload.

Placebo Comparator: Unsuccess placebo
Participants who lost less than 15% body weight at 2 years post-roux-en-y bypass surgery will receive placebo infusion prior to an intake test.
Drug: Placebo
Infusion of 0.9% saline solution (placebo infusion) for 60 minutes. An average of 12.1 ml will be infused in a forearm vein during an oral glucose (50 g) preload.




Primary Outcome Measures :
  1. Successful Weight Loss [ Time Frame: 2 years ]
    % Excess body weight lost


Secondary Outcome Measures :
  1. Intake amount in grams consumed in a food intake capacity test [ Time Frame: 2 years ]
    Intake amount in grams consumed in a food intake capacity test

  2. Fullness levels based on a rating scale after food intake capacity test [ Time Frame: 2 years ]
    Fullness levels based on a rating scale after food intake capacity test

  3. Sickness levels based on a rating scale after food intake capacity test [ Time Frame: 2 years ]
    Sickness levels based on a rating scale after food intake capacity test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI greater than 35kg/m2
  • BMI less than 50 kg/m2
  • Preparing to undergo Roux-en-Y gastric bypass surgery at St. Luke-Roosevelt Hospital
  • Within the 18-65 age range

Exclusion Criteria:

  • Type 2 diabetes
  • Cigarette smoker
  • Active cancer
  • Severe respiratory or cardiac failure
  • Currently pregnant
  • Phenylketonuria
  • Unstable angina
  • Recent stroke
  • Current therapy that may affect glucose metabolism such as glucocorticoids, adrenergic agents;
  • Active infection
  • Kidney failure
  • Severe liver dysfunction
  • Pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697253


Contacts
Contact: Ari Shechter, PhD 212-851-5578 as4874@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center - Russ Berrie Building Recruiting
New York, New York, United States, 10032
Contact: Harry R Kissileff, PhD    212-851-5133    hrk2@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ari Shechter, PhD Columbia University

Responsible Party: Ari Shechter, Assistant Professor of Medical Sciences (in Medicine) at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT02697253     History of Changes
Other Study ID Numbers: AAAQ1904
R01DK108643 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ari Shechter, Columbia University:
Roux-en-Y Bariatric Surgery
Psychosocial Variables
Behavioral Variables
Weight Loss
Food Intake
GLP-1
Reinforcing Value of Food
Exendin 9-39

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms