Weight Loss Following Gastric Bypass or Sleeve Surgery

N/ACompletedNCT02070081

University of Copenhagen55 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Roux-en-Y gastric bypass surgery or sleeve surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark Exclusion Criteria: * Inability to comply with the study protocol

Locations (1)

Faculty of Science, NEXS

Frederiksberg, Denmark

Outcomes

Primary Outcomes

Weight loss

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

Secondary Outcomes

Metabolic profile

Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids

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

Physical activity

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

Appetite sensation

Following a test meal with the use of visual analogue scales (VAS)

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

Taste preferences and taste perception

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

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

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

Data from ClinicalTrials.gov

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