NCT02070081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

3.1 years

First QC Date

February 18, 2014

Last Update Submit

May 22, 2019

Conditions

Obesity

Keywords

ObesityBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

Secondary Outcomes (14)

  • Metabolic profile

    3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively

  • Physical activity

    3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively

  • Appetite sensation

    3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

  • Taste preferences and taste perception

    3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

  • Mental health

    3 month preoperatively, 6 month postoperatively and 18 month postoperatively

  • +9 more secondary outcomes

Study Arms (1)

Surgery

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

Interventions

Roux-en-Y gastric bypass surgery or sleeve surgeryPROCEDURE
Surgery

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Science, NEXS

Frederiksberg, 1958, Denmark

Location

Related Publications (6)

  • Nielsen MS, Ritz C, Wewer Albrechtsen NJ, Holst JJ, le Roux CW, Sjodin A. Oxyntomodulin and Glicentin May Predict the Effect of Bariatric Surgery on Food Preferences and Weight Loss. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa061. doi: 10.1210/clinem/dgaa061.

    PMID: 32016415DERIVED

  • Nielsen MS, Andersen INSK, Lange B, Ritz C, le Roux CW, Schmidt JB, Sjodin A, Bredie WLP. Bariatric Surgery Leads to Short-Term Effects on Sweet Taste Sensitivity and Hedonic Evaluation of Fatty Food Stimuli. Obesity (Silver Spring). 2019 Nov;27(11):1796-1804. doi: 10.1002/oby.22589. Epub 2019 Sep 26.

    PMID: 31556242DERIVED

  • Taekker L, Lunn S. The effect of mental health on weight loss after bariatric surgery. Dan Med J. 2019 Feb;66(2):A5532.

    PMID: 30722827DERIVED

  • Sondergaard Nielsen M, Rasmussen S, Just Christensen B, Ritz C, le Roux CW, Berg Schmidt J, Sjodin A. Bariatric Surgery Does Not Affect Food Preferences, but Individual Changes in Food Preferences May Predict Weight Loss. Obesity (Silver Spring). 2018 Dec;26(12):1879-1887. doi: 10.1002/oby.22272. Epub 2018 Nov 13.

    PMID: 30421858DERIVED

  • Christensen BJ, Schmidt JB, Nielsen MS, Taekker L, Holm L, Lunn S, Bredie WLP, Ritz C, Holst JJ, Hansen T, Hilbert A, le Roux CW, Hulme OJ, Siebner H, Morville T, Naver L, Floyd AK, Sjodin A. Patient profiling for success after weight loss surgery (GO Bypass study): An interdisciplinary study protocol. Contemp Clin Trials Commun. 2018 Feb 17;10:121-130. doi: 10.1016/j.conctc.2018.02.002. eCollection 2018 Jun.

    PMID: 30023446DERIVED

  • Nielsen MS, Christensen BJ, Ritz C, Rasmussen S, Hansen TT, Bredie WLP, le Roux CW, Sjodin A, Schmidt JB. Roux-En-Y Gastric Bypass and Sleeve Gastrectomy Does Not Affect Food Preferences When Assessed by an Ad libitum Buffet Meal. Obes Surg. 2017 Oct;27(10):2599-2605. doi: 10.1007/s11695-017-2678-6.

    PMID: 28411313DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., MD, Head of Department of Nutrition, Exercise and Sports

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 24, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

DK(1)