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)

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

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NCT05987631


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