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Completed

NCT Number: NCT02070081

Weight Loss Following Gastric Bypass or Sleeve Surgery

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.

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Key information

Conditions

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

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Science, NEXS

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to comply with the study protocol

Treatment and study plan

Roux-en-Y gastric bypass surgery or sleeve surgery

Procedure

Primary outcomes

  1. Weight loss

    Time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary outcomes

  1. 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

  2. Physical activity

    Time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively

  3. 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)

  4. 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

  5. Mental health

    Time frame: 3 month preoperatively, 6 month postoperatively and 18 month postoperatively

  6. Social resources

    Time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

  7. Gut microbiota

    Time frame: 1 week preoperatively, 6 month postoperatively

  8. 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

  9. Bile acids and fibroblast growth factors

    Time frame: 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively

  10. Genetics

    Time frame: 3 month preoperatively

  11. Body composition

    Time frame: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

    By DXA scans

  12. Cortisol

    Time frame: 3 month preoperatively and 18 month postoperatively

    Measured in hair

  13. Neural activity in reward-processing brain centers

    Time frame: preoperatively and 6 month postoperatively

    By functional magnetic resonance imaging (fmri)

  14. Rewarding value of food

    Time frame: preoperatively and 6 month postoperatively

    Behavioral test

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
  • Copenhagen University Hospital, Hvidovre

Registry information

Official study title

Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2014
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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