Weight Loss Following Gastric Bypass or Sleeve Surgery

Overview

The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery. The specific aims are to evaluate: a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.

Full Title of Study: “Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2017

Interventions

  • Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery

Arms, Groups and Cohorts

  • Experimental: Surgery

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary Measures

  • Metabolic profile
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
    • Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids
  • Physical activity
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
  • Appetite sensation
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
    • Following a test meal with the use of visual analogue scales (VAS)
  • Taste preferences and taste perception
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
    • Sensory tests, picture displays (all visits) and an ad libitum test meals (3 months preoperatively and 6 months postoperatively) are used to investigate changes in taste and food preferences (liking and wanting) and taste perception
  • Mental health
    • Time Frame: 3 month preoperatively, 6 month postoperatively and 18 month postoperatively
  • Social resources
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
  • Gut microbiota
    • Time Frame: 1 week preoperatively, 6 month postoperatively
  • Appetite-regulating hormones
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
    • GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
  • Bile acids and fibroblast growth factors
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
  • Genetics
    • Time Frame: 3 month preoperatively
  • Body composition
    • Time Frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
    • By DXA scans
  • Cortisol
    • Time Frame: 3 month preoperatively and 18 month postoperatively
    • Measured in hair
  • Neural activity in reward-processing brain centers
    • Time Frame: preoperatively and 6 month postoperatively
    • By functional magnetic resonance imaging (fmri)
  • Rewarding value of food
    • Time Frame: preoperatively and 6 month postoperatively
    • Behavioral test

Participating in This Clinical Trial

Inclusion Criteria

  • All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark Exclusion Criteria:

  • Inability to comply with the study protocol

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Copenhagen
  • Collaborator
    • Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arne Astrup, Prof., MD, Head of Department of Nutrition, Exercise and Sports – University of Copenhagen

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