Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Recruiting · NCT05987631 · Observational (researchers observe without assigning treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →What this trial is about
In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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:
- Ability to provide informed consent
- Patient is ≥ 18 and ≤ 75 years old
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
- Patients scheduled for 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 hormones on insulin sensitivity)
Exclusion criteria
- 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 Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone
- Diabetes mellitus type 2
Where it is running
3 locations listed.
- Nederlandse Obesitas Kliniek Gouda - Gouda, South Holland, Netherlands
- Nederlandse Obesitas Kliniek Den Haag - The Hague, South Holland, Netherlands
- Nederlandse Obesitas Kliniek Nieuwegein - Nieuwegein, Utrecht, Netherlands