Preoperative predictors of weight loss and improved metabolic health after bariatric surgery
- Conditions
- Obesityoverweight100184241000301810017998
- Registration Number
- NL-OMON56270
- Lead Sponsor
- Endocrinologie&metabolisme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
* Ability to provide informed consent
* Patient is >= 18 and <= 75 years old
* BMI >= 40 kg/m2 or >= 35 kg/m2 with obesity related comorbidity
* Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or
Sleeve Gastrectomy (SG)
* Stable weight 3 months prior to inclusion weight (<10% change in body weight
for 3 months prior to assessments)
In order to be eligible to participate in the subgroup of this study, we will
use the following inclusion criteria:
* We will include only patients who will undergo RYGB;
* Patients who are insulin resistant (impaired fasting glucose (> 5.6 mmol/L)
or fasting insulin > 74 pmol/L)
* Postmenopausal women (to prevent bias due to the effect of sex homones on
insulin sensitivity)
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Patients who do not understand the patient information letter
* Any actual medical condition except for obesity related health issues or well
treated hypothyroidism
* Pregnancy anticipated in the first two years following surgery
A potential subject who meet the following criteria will be excluded from
participation in the subgroup of this study:
* Coagulation disorders and/or use anticoagulants
* Use of any medication except for statins, antihypertensives (except for ACE-
or angiotensin receptor blockers) and thyroid hormone
* Diabetes mellitus type 2
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the preoperative blood samples and urine used for<br /><br>GWAS analysis, urine samples will be collected to evaluate predictors of<br /><br>response to surgery , based on results of GWAS analysis and omics analyses<br /><br>performed in previous SOPHIA studies. </p><br>
- Secondary Outcome Measures
Name Time Method