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Weight Loss Following Gastric Bypass or Sleeve Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02070081
Enrollment
55
Registered
2014-02-24
Start date
2014-03-31
Completion date
2017-04-30
Last updated
2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Bariatric surgery

Brief summary

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.

Interventions

PROCEDURERoux-en-Y gastric bypass surgery or sleeve surgery

Sponsors

Bariatric Clinic, Department of Surgery, Køge Hospital, Denmark
CollaboratorUNKNOWN
The Danish Research Centre for Magnetic Resonance, Hvidovre Hospital, Denmark
CollaboratorUNKNOWN
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inability to comply with the study protocol

Design outcomes

Primary

MeasureTime frame
Weight loss3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary

MeasureTime frameDescription
Gut microbiota1 week preoperatively, 6 month postoperatively
Appetite-regulating hormones3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperativelyGLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin
Metabolic profile3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperativelyInsulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids
Physical activity3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Appetite sensation3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperativelyFollowing a test meal with the use of visual analogue scales (VAS)
Taste preferences and taste perception3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperativelySensory 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
Social resources3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively
Bile acids and fibroblast growth factors3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively
Genetics3 month preoperatively
Body composition3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperativelyBy DXA scans
Cortisol3 month preoperatively and 18 month postoperativelyMeasured in hair
Neural activity in reward-processing brain centerspreoperatively and 6 month postoperativelyBy functional magnetic resonance imaging (fmri)
Rewarding value of foodpreoperatively and 6 month postoperativelyBehavioral test
Mental health3 month preoperatively, 6 month postoperatively and 18 month postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026