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Metabolism and Bariatric Surgery Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371368
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Judith Korner, Columbia University

Brief Summary:
The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall research plan is a non-randomized prospective study of 3 different WL interventions and a lean and an obese healthy control group.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Procedure: Roux-en-Y Gastric Bypass Procedure: Sleeve Gastrectomy Behavioral: Very Low Calorie Diet Not Applicable

Detailed Description:
Weight loss (WL) improves obesity-related co-morbidities such as type 2 diabetes mellitus (DM). Unfortunately, WL through life-style interventions has a high degree of recidivism and the paucity of safe, effective and affordable pharmacotherapy together with an increase in the prevalence of morbid obesity has led to a rise in bariatric procedures. Clinical trials in patients with DM show that improvements in glycemia vary between procedures and occur in the following order: Roux-en-Y gastric bypass (RYGB) > sleeve gastrectomy (SG) > laparoscopic adjustable gastric banding (LAGB) > medical/life-style therapy. This order mirrors the amount of WL with each intervention and is a major driver of glycemic improvement. The investigators have shown profound changes unique to RYGB and SG in levels of hormones that make up the "gut-brain" and "enteroinsular" axes. The association of some of these hormones with insulin sensitivity (IS) and glycemia independent of WL strongly suggests that glycemic improvements after surgery occur in part through pathways that are distinct from just calorie restriction. This study builds on results showing that levels of fibroblast growth factor 19 (FGF19), a protein secreted by intestinal cells, are increased after RYGB and SG but not after low calorie diet (LCD). This difference may affect hormones that control the stress response to weight loss. The investigators will explore differences in hormones of the gut that affect appetite, body weight, and stress response in healthy lean and obese individuals. Obese individuals will also be studied before and after 15% body weight loss induced by LCD, RYGB or SG, and again at 1 year after study enrollment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic and Endocrine Effects of Bariatric Surgery
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gastric Bypass Diabetic and Non-diabetic
Roux-en-Y gastric bypass surgery
Procedure: Roux-en-Y Gastric Bypass
NOTE: The surgery is NOT paid for by the study
Other Name: RYGBP

Active Comparator: Sleeve Gastrectomy Diabetic and Non-diabetic
sleeve gastrectomy surgery
Procedure: Sleeve Gastrectomy
NOTE: The surgery is NOT paid for by the study
Other Name: SG

Active Comparator: Very Low Calorie Diet Diabetic and Non-diabetic
very low calorie diet
Behavioral: Very Low Calorie Diet
Weight loss with calorie restricted liquid diet. Subjects will be placed on a 800 kcal/day diet with a meal replacement (Optifast) provided by the investigator for 12 weeks. Then, transitioning to a higher calorie diet intake up to a year. Subjects will be closely monitored by study dietitian
Other Name: VLCD

No Intervention: Obese Control
Non-diabetic obese subjects
No Intervention: Lean Control Group
Non-diabetic lean subjects



Primary Outcome Measures :
  1. Change in urine free cortisol level [ Time Frame: Baseline and 1 year ]
    A linear mixed effects model will be used to compare the cortisol changes between the LCD and the surgery groups. Specifically, cortisol change will be modeled as longitudinal outcome, and the main predictors are time and treatment group, and the time-treatment interaction.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Men and women Ages 18-65 Years Old

Exclusion Criteria:

  1. Altered Sleep-wake Cycle
  2. Type 1 or 2 diabetes
  3. Previous Bariatric Surgery
  4. Lactose Intolerance
  5. Any Special Diet restrictions.
  6. Use of medications that may affect body weight at screening or during a 3 month period prior.
  7. Untreated thyroid disease
  8. Other medical conditions like Cushing's, acromegaly, Hearth failure, Crohn's disease, etc
  9. Pregnancy
  10. Tobacco or opioid use
  11. Alcohol dependence
  12. > 3% weight change over the 3month period prior to screening
  13. Unwillingness to maintain current level of physical activity over duration of study period

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): NCT03371368


Contacts
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Contact: Judith Korner, MD, PhD (212) 305-3725 jk181@cumc.columbia.edu
Contact: Gerardo Febres, MD 212-342-0281 gjf41@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Judith Korner, M.D, PhD    212-305-3725    jk181@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Judith Korner, MD, PhD Columbia University
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Responsible Party: Judith Korner, Professor of Medicine at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT03371368    
Other Study ID Numbers: AAAR3662
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judith Korner, Columbia University:
Obesity
Insulin Resistance
Bariatric Surgery
Gastric Bypass
Sleeve Gastrectomy
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases