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Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
RECRUITINGSponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Actively Recruiting
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started2023-01-19
Est. completion2024-08-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05987631
Summary
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
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
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
Conditions5
Bariatric Surgery CandidateFeeding BehaviorInsulin SensitivityObesity, MorbidWeight Loss
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Actively Recruiting
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started2023-01-19
Est. completion2024-08-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05987631