RecruitingNCT05987631
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
1,200 participants
Start Date
Jan 19, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria11
- 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)
- 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 Criteria6
- 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
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Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05987631
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